It seems the labeling and packaging is all set hopefully news this week on patent confirmation www.xechemnigeria.org
NICOSAN™ 350mg NICOSAN™ Products under development
NICOSAN™ 250mg NICOSAN™ Products under development
In July, 2002, Xechem acquired an exclusive, worldwide license to develop NICOSAN™ (HEMOXIN™ in the US) from the Nigerian government and, subsequently, received U.S. orphan drug status for HEMOXIN™ from the FDA in August, 2003. The product is made from four botanical species indigenous to Nigeria. NICOSAN™ is produced there today by Xechem. The Company expects to launch NICOSAN™ in Nigeria’s 4,000,000 SCD patient market, the world’s largest SCD market, in 2005. SCD, a devastating hereditary blood disorder characterized by acute painful crisis, organ damage, anemia and early death, affects over 80,000 African Americans in the U.S. alone. Based on published data and human experience, the Company believes the successful clinical development of HEMOXIN™ represents an unusually low risk. In phase II human studies in Nigeria, published in Phytomedecine, HEMOXIN™ was shown to be safe in all patients and effective in approximately 80% of patients. As published in the May 2003 issue of the British Journal of Hematology, Asakura and colleagues from Children’s Hospital of Philadelphia (CHOP) and the University of Pennsylvania demonstrated the anti-sickling effects of HEMOXIN™ in transgenic mice. This lends significant credibility to the Nigerian human experience to initiate clinical trials in the U.S.
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Posted by JL on :
I donno is the pump team running XKEM ready?
Posted by topsail on :
I think the pump team went on vacation. Sure wish they'd come back soon, PPS keeps walking down.
Posted by J_U_ICE on :
I wish they would come back to I'm sick of waiting for a run
Posted by J_U_ICE on :
INTERESTING READ
Xechem Pharmaceuticals [XKEM.OB]is in an interesting position here.They have a Sickle Cell treatment called Nicosan/Hemoxin,the only effective treatment for Sickle Cell Disease in the world other than the highly toxic chemo drug made by BMS called Hydroxyurea.Nicosan/hemoxin is a combination of 4 herbs indiginous to the jungles of Nigeria in Africa.Xechem's production facility in Abuja,Nigeria is very close to being completed & ready for production of Nicosan.They are presently awaiting word from the Nigerian drug agency NAFDAC for approval of Nicosan.Lets back up.Nicosan is made from a combination of 4 herbs..so is it a drug or a herbal treatment? It's both actually.We believe very strongly that NAFDAC will approve Nicosan anyday now as a "drug" but what about the FDA & marketing the product in the U.S.?If Nicosan is marketed in the U.S. as a herbal treatment they do not need the blessing/approval from the FDA for starters.The FDA approval process for a "drug" can take as long as 6- 8 years & cost up to 800 million dollars.In other words it would be a long,long,long time before Nicosan was available in the U.S.as a drug to treat Sickle Cell disease.That's the catch.The FDA says this: only a "drug" can cure disease.So the answer to getting Nicosan/Hemoxin into the U.S. market? Yep.. as a "herbal treatment" for Sickle Cell Disease.No need for approval from the FDA.No 6-8 years of harassment,setbacks & everyother roadblock the FDA would surely set up to block the approval of Nicosan to protect the sales of Bristol- meyer,Squibb's Hydroxyurea.Yes I know how the FDA works...so as of right now Xechem Nigeria website is up [& there is a order form that can be filled out to order Nicosan online directly from the webpage [its not working as Nicosan is still not available... yet].Sales in the U.S. could begin as soon as production starts...remember as long as you don't make any claims that Nicosan cures anything it can be sold in the U.S. as a "herbal treatment"you can say it is for SCD but we don't claim Nicosan does anything...you know how it works..health food stores etc....Nicosan does not cure SCD anyway.It supresses the symptoms of the horrible disease.In test studies 90% of patients achieved significant pain reduction & moreover 73% of the patients achieved TOTAL REMISSION from the disease after just 6 months of Nicosan therapy.Now you are wondering how does Xechem protect Nicosan as a herbal treatment?That is where the lawsuit that Xechem won last year over BMS is so very important.Xechem proved that they held the rights to the herbal Cancer treatment "Paciltaxel" that BMS stepped all over & violated their patent by making the synthetic Cancer drug "Taxel"..the judge in the case agreed with Xechem & awarded them 4.2 million.The money is not important...what is very important is that BMS tried to copy Xechem's herbal Cancer treatment & lost.So if any big pharmaceutical company was to copy Nicosan synthetically,Xechem's legal council would simply show a judge the verdict from the Taxel-Paciltaxel case from 2005 & the judge would rule in Xechem's favor.Judges go by previous identical lawsuits to make there verdicts 99% of the time.So if Xechem sells Nicosan in the U.S.as a herbal treatment,it would be protected by that BMS-Xechem Taxel verdict IMO. NIPRD, a Nigerian agency holds the patent for Nicosan/Hemoxin & that would offer additional protection.Xechem says once they get approval from NAFDAC they will begin selling Nicosan immediately & I believe they can sell Nicosan thru their website all over the world eventually including the u.S. market.The only country that presented a problem was the U.S. & by selling it as an herbal treatment that is no longer a problem.Now here is the good part.XKEM.OB is currently at .012 a share.The chairman & CEO of Xechem says that sales of Nicosan in Nigeria alone,should be in excess of $500,000,000 a year.There are an estimated 12 million people in Africa that suffer from SCD.Using Dr Pandeys $$$ figures,just Africa represents 1.7 billion in Nicosan sales per year as Nicosan needs to be taken continually to be effective.XKEM.OB has 882 million O/S.That would give XKEM a share price of $1.93 per share if you figure revenue from sales just in Africa.Sales will be limited to start as the production facility in Abuja is only big enough to supply Nigeria in the very beginning... until the 8.2 million production facility build out is complete.
Posted by J_U_ICE on :
another interesting post from IHUB
Hey Gang,
I just spent about 15 minutes on the phone with Steve Burg. He was returning my call from yesterday prior to when I called Howard. Great conversation - Best yet by far.
We discussed why no PR on the new factory/web site.. He told me that the NICOSAN application is the largest event EVER to be placed in front of NAFDAC. 95% of all drugs used by Nigerians are imported. NICOSAN would become the LARGEST drug ever to be produced and distributed in Nigerian. He also said that the factory also needs to be approved by NAFDAC. Both the drug formula and the commercialization/development of the drug are before NAFDAC as we speak. This air a very complicated process, and a lot of politics are involved with this. Pandey is working hard every day to get this done. THE COMPANY IS AFRAID TO ISSUE ANY PR'S RIGHT NOW, BECAUSE THEY DON'T WANT TO UPSET/DISTURB NAFDAC IN ANYWAY. THE PROCESS IS SO SENSITIVE, AND NIGERIA HAS COMPLETE AND 100% CONTROL. Any screw up by XKEM, could cost dearly. No PR until final approval.
We also discussed the financing and dilution issues. No more shares have been issued, and the company is VERY CLOSE to signing a deal with UPS which Steve said is 100% not dilutive. They are doing everything possible right now to preserve shareholder value, and eliminate future dilution. The loan from UPS would support expansion of the plant in Nigeria as well as ongoing cash flow requirements until sales prop up. HE TOLD ME THAT XKEM IS REARING TO GO, AND READY TO START BLASTING OUT SALES AS SOON AS APPROVAL IS GRANTED.
We also discussed the fact the XKEM has completed testing in other parts of the world to find out where these plants can be grown outside of Nigeria. They have identified several regions in India where these plants can be grown, and have begun looking into the possibility of setting up a manufacturing facility outside of Nigeria as well.
AS FAR AS THE Q2 SALES DISCUSSED IN THE 10K. STEVE FEELS THAT THIS IS A GOOD TIME FRAME, AND EXPECTS APPROVAL ANY DAY.
The company has remained in quite period right now, because they do not want to create any adverse reactions from NAFDAC. When approval is finally granted. Look out. The PR campaign will be a machine and unstoppable.
Posted by BULListic on :
XKEM getting a lot of hits this morning? Up to 125x126 on 95% buys, perhaps the big news on the Nigerian Express is near.
Posted by J_U_ICE on :
quote:Originally posted by BULListic: XKEM getting a lot of hits this morning? Up to 125x126 on 95% buys, perhaps the big news on the Nigerian Express is near.
I was going to post on this but was too busy/lazy to search for the thread Thanks BULListic. caught this on IHUB last Night:
XKEM, check this out..........
Folks, I'm tellin ya's... I can't believe how BIG this is, that an Official Nigerian web site "NATIONAL DATA CENTER FOR SCIENCE & TECHNOLOGY" now states... "5. Commercialization of Pharmaceutical Research and Development Results: A major landmark in this direction is the successful development of the sickle cell drug, NICOSAN."
I had a great conversation with Steve Burg yesterday afternoon. First I asked him about previous pr's and he said he doesn't have them in front of him. Frankly I didn't push it because to me they are in the past. Then I asked him if phase 3 has been done in Nigeria and he said absolutely. He said they are going to redo it again later, but will have no affect on drug getting approved. The next question was financing. He said they are still working on conventional financing, but also have a group in place to do equity financing. He said if they go with the equity financing, it will be a lot better than it has been. Steve said they don't need as much money now, because they are so close to getting cash flow. I told him that in my opinion there is no way Nigeria won't approve the drug. He said he would be shocked if it didn't go through. He said Nigeria has a lot riding on this also. He said Dr Pandy left last night to be in Nigeria for the next week. He is hoping they will get updated when Pandy is there. We talked about pricing in Nigeria and he said they haven't set a price exactly yet. I mentioned 15. - 20. dollars per month and he said that is probably the range. I said do you expect to get at least 2 million people using it right away, and he said yes, that should be about right. At 20 per month that is almost 500 million per year. Than he said that even though the United States has only about 80,000 with the disease, he expects it to be worth a lot because they will be able to charge a lot for the drug here, like in the thousands per year. He said it will be a reimbursible treatment from health insurance. He said he has been to Nigeria and see how much good the drug does. He said it is amazing. Do your own dd and this is jmo, but I am not selling now.
Posted by topsail on :
J_U_ICE: Thanks for posting what you've found out. I've tried contacting Xechem by email, but so far no response. You answered most of my pressing questions, so thanks. Good to see some movement, been stagnant for too long.
GLTA
Posted by J_U_ICE on :
Way too long but when it hits it will be huge. The company doesn't put out PR unless it is substantial which is great. I'm so sick of the BS PR like USXP
Posted by J_U_ICE on :
2x volume green day nice change of pace. Maybe it's a sign of things to come
Posted by J_U_ICE on :
The chart is set up for this to move, crazy after hours volume!!!!!! this is ready to run!!!!!!!!!!
Posted by UVCLRules on :
Time to Rock the Casbah!
Posted by J_U_ICE on :
AMERICAN BULLS BUY CONFIRMED XKEM
XECHEM INTL INC Daily Commentary
Our system posted a BUY CONFIRMED today. The previous SELL recommendation was issued on 05.05.2006 (4) days ago, when the stock price was 0.0118. Since then XKEM has gained 13.56% .
The recent bullish formation leading to the BUY-IF signal is confirmed today. The market seems ready for a new bullish move. Though the market opened lower today, the day’s activity created a white candlestick that closed above the previous close. This is a valid confirmation criterion.
The significant failure of the previous SELL signal is unfortunately confirmed too. Our shot went away this time. It is a fact that such signal failures are more unlikely for higher rated stocks, but it is not possible to deal with all the vagaries of the stock market. The signal system, however, continues to do an excellent job in the overall, despite such failures. This can be seen easily with a quick glance to the signal history table.
We hope that you bought this stock and still have the chance to profit from the later phase of the bullish attack. Today your important benchmark was the previous close. You were supposed to watch the session carefully, feel its bullish tendency despite the lower opening, and go long after making sure that the prices stay over the previous close.
If you bought, continue to hold this stock until the confirmation of the next SELL-IF signal. You are on relatively safe grounds as long as the future prices continue to trade above the benchmark price and if an emergency warning is not issued. What to do if you did not buy? Maybe, you did not have time to follow the session or you simply delegated the delicate job of confirmation to us. Well, it is a bit late, but not too late. You may still find suitable prices for buying in the following sessions and still profit in case of a sustained bullish move.
The market is currently cold for short-sellers. Avoid any short sales and cover the short positions immediately if there are any. We erred significantly on the short side last time, but we are sure that you may easily cover your losses (if any) by basing your future trades on our signal system.
BUY CONFIRMED
0.0134 +0.0014 +11.67%
Candlestick Analysis Today’s Candlestick Patterns: White Candlestick
Today a White Candlestick was formed. This represents normal buying pressure
Posted by J_U_ICE on :
I think this is set up to move
Posted by topsail on :
Volume has picked up, but not much movement. Still glad to see interest picking up though. Hopefully we'll have an announcement soon stating the approval has been made, the factory is ready and revenue will commence.
GLTA
Posted by GreenBaronZ on :
i got some shares today...I think this stock will be hot for June...
I picked some cheap shares up during the dip today...going to wait til June when they launch their product...I truly believe this will be big.
Posted by topsail on :
J_U_ICE: I see your on the RSHN board as well. Own any other pennys? I'm holding RSHN, XKEM and IGTG. I'm holding them all long, although I may sell a few shares of XKEM when it pops to cover my investment. In your talks with XKEM, was there any mention of concerns with the current political climate in Nigeria?
Posted by J_U_ICE on :
quote:Originally posted by topsail: J_U_ICE: I see your on the RSHN board as well. Own any other pennys? I'm holding RSHN, XKEM and IGTG. I'm holding them all long, although I may sell a few shares of XKEM when it pops to cover my investment. In your talks with XKEM, was there any mention of concerns with the current political climate in Nigeria?
Topsail, sorry it took me so long to get back to you. I have flip RSHN a couple of times for some nice coin. Now I'm riding mostly free shares but I'm in for the long-term. My only other long-term pennies are XKEM BIGN and VNBL. The XKEMconversations I've posted were taken from another poster on a different message board. I was just getting out all the info I had found. Sorry for the mixup
Posted by GreenBaronZ on :
this one getting alot of talk from the other boards.
Posted by J_U_ICE on :
THE DEVELOPMENT OF NICOSAN TM/HEMOXIN TM A DRUG FOR THE MANAGEMENT OF SICKLE CELL DISEASE. 7.0 HISTORICAL BACKGROUND NICOSANTM/HEMOXINTM (formerly NIPRISAN) is a drug first developed by the National Institute for Pharmaceutical Research and Development (NIPRD) for the management of Sickle Cell Disease (SCD). It consists of a mixture of extracts from four tropical plants some of which are cultivated and others found in the wild both within and outside Nigeria. The story of NICOSANTM/HEMOXINTM will be incomplete without acknowledging some of the great minds, which have contributed immensely towards its development. Historically, a similar remedy was mentioned in the book titled “Iwosan” published by the late Dr. Odumosu at the turn of the century. However, the modern day origin of what later became patented as NIPRISAN was due to the late Rev. Paul Ogunyale, then Pastor of the First Baptist Church in Ibadan, Oyo State, Nigeria, who brought the attention of Prof. Charles Wambebe, former Director General, NIPRD in late 1992 to a herbal recipe of the drug. From 1992 to 2001, Prof. Wambebe and his team of researchers at NIPRD, supported by the Federal Government of Nigeria (FGN) and the World Health Organization (WHO), worked tirelessly to develop NIPRISAN as a potent drug for the management of SCD and was patented in the United States of America under the leadership of Prof. Wambebe. After the retirement of Prof. Wambebe from NIPRID, his successor, Dr. Uford S. Inyang continued tirelessly with more developmental work in taking NIPRISAN to a higher level. 7.1 THE BIRTH OF NICOSANTM/HEMOXINTM In August 2001, a joint conference on biotechnology was organized at Cook College, New Brunswick, NJ between the Sheda Science and Technology Complex (SHESTCO), Abuja and Rutgers University under the leadership of Dr. Soji Adelaja, who was then Dean of Research at Cook College and New Jersey Agricultural Experiment Station (Cook/NJAES), and Dr. Albert Ayeni, then Weed Scientist at Cook/NJAES and currently Coordinator of International Programs of Cook/NJAES. Dr. Ramesh C. Pandey, Chairman & CEO, Xechem International, Inc., represented his company at this conference. What transpired during and after the conference propelled Dr. Pandey to explore the possibilities in the applications of biotechnology for drug production in Nigeria. At the instance of Prof. Turner T. Isoun, the Honourable Minister of Science and Technology, Dr. Pandey visited Nigeria for the first time in October 2001 with Dr. Albert Ayeni. This visit aroused in Dr. Pandey the interest in exploiting biotechnology for drug development in Nigeria. The first product of interest, NIPRISAN was thus, introduced to him by Dr. Ayodele Coker, the Director- General of SHESTCO, and later by Dr. Uford S. Inyang, the Director- General of NIPRID. 1 In July 2002, negotiations were successfully concluded between NIPRD and Xechem International under the direction of Prof. A. B. C. Nwosu, then the Honourable Minister of Health. Xechem International was granted the exclusive rights for development, production and marketing of NIPRISAN. To give effect to the agreement, Xechem Pharmaceuticals Nigeria Ltd, which is located within the premises of the Sheda Science and Technology Complex, was incorporated in 2002. 7.2 ABOUT SICKLE CELL DISEASE: Sickle cell Disease is a genetic blood disorder caused by an abnormality in the hemoglobin molecule as depicted in the figure below. The condition causes the production of abnormal hemoglobin that contains portions that stick together after the release of oxygen. This phenomenon produces stiff, sickle shaped red blood cells that do not flow freely through blood vessels. These sickle shaped cells create clogs in the blood vessels, which prevent the flow of normal hemoglobin and oxygen round the body. The result is severe pain or “crises”, ulcers, organ and tissue damage and breakdown, which eventually lead to stroke and acute chest pain. The body’s immune system also attacks and seeks to destroy the abnormally shaped cells, often leaving the body with an insufficient number of normal oxygen- carrying red blood cells, which in turn results in anemic condition that manifest in fatigue and enhanced susceptibility to infection. It is estimated that there are 10 million sufferers of SCD worldwide, of which about 4 million are Nigerians. Sickle Cells Normal Cells Repeated crisis can also result in damage to the kidneys, lungs, bones, eyes and the central nervous system. The most feared complication for children with SCD is a stroke which affects infants as young as 18 months. Many children with SCD do not survive infancy or early childhood. Adults with SCD often experience a reduction in the quality of life due to severe physical problems such as pain, Hard- foot syndrome and acute lung complications that can result in death. Frequent episode of severe bone pain, crises and hospitalization significantly affect the lives of these patients. It limits their ability to participate in normal physical activities, thus retarding their social 2 and economic advancement. It also deprives them of the joy of living life to the fullest and instills the fear of early death in them. Before the advent for NICOSANTM/HEMOXINTM the only known cure for the disease is a bone marrow transplant to replace defective red blood cells with donor healthy cells. Treatment has generally consisted of supporting therapies, which include folic acid for anemia, penicillin to prevent infections, pneumococcal and influenza vaccination, pain killing drugs and intravenous injection of fluids. In the United States of America, Hydroxyurea is the only drug approved by the Food and Drug Administration (FDA) for the treatment of SCD. It is very expensive and toxic and patients treated with hydroxyurea exhibit severe side effects. 7.3 HOPE FOR THE SICKLERS. NICOSANTM/HEMOXINTM is a non- toxic, phytopharmaceutical product composed of extracts from four tropical plants, seeds, stems, fruits and leaves. Each plant is indispensable in the manufacturing of NICOSANTM/HEMOXINTM. Xechem Pharmaceuticals Nigeria Limited has developed refined and standardized small- scale formulations of NICOSANTM/HEMOXINTM for consistent production in strict compliance with the recommended procedures and policies of the WHO. NICOSANTM/HEMOXINTM has already undergone phase I and phase II clinical trials conducted in Nigeria by the NIPRD. Results from the phase III trials, if found satisfactory, will form the final basis for an application to the National Agency for Food and Drug Administration and Control (NAFDAC) for regulatory approval. Further laboratory testing among others have also been done at the National Heart, Lung and Blood Institute - Sickle Cell Disease Reference Laboratory (NHLBI-SCDR Lab) located at the Children’s Hospital, Philadelphia, Pennsylvania, USA. The results of these trials show that NICOSANTM/HEMOXINTM drastically reduced the degree of sickle cell formation, and the frequency and severity of SCD crises. Liver and kidney functions remained normal and patients gained appreciable weight. No adverse effects were reported during the trials. These clinical studies suggest that NICOSANTM is a safe and efficacious phytomedicine for the management of SCD. It may have just paved the way for ending the misery and pain of millions of SCD sufferers in Nigeria and the world at large. Through the instrumentality of Dr. Pandey, and based on the background of work done at the Children’s Hospital, Philadelphia (CHOP) and other published literature in various indexed journals, on August 15th, 2003, NICOSAN™ (NIPRISAN) was granted an Orphan Drug status by the Food and Drug Administration of the United States of America (US-FDA). The Orphan Drug designation, entitles a company to various incentives including the waiver of Regulatory filing fees, access to potential funding for non- clinical and clinical research to generate required data for marketing approval, and seven years of marketing exclusivity once approved by the FDA. 3 This was a major break- through since it was a far- fetched possibility that the US-FDA would designate NICOSANTM (NIPRISAN) Orphan Drug status. The Orphan Drug status has thus, added credibility and international acceptability to NICOSANTM (NIPRISAN) as a potent drug for the management of SCD. 4
Posted by pay up on :
From RB, By: alexng00 15 May 2006, 12:58 PM EDT Msg. 31490 of 31685
In addition to the feedbacks provided by Steve Burg, I called directly NAFDAC organisation this morning to get other confirmation and updates. I pick up the phone number from the NAFDAC website and reach a person within NAFDAC who provides me another number of a responsible person,I call that person and I ask her about the submission from Xechem for Nicosan, she checks the system and confirms to me that Xechem has submitted the master drug file in March, she said they submitted the Nicosan product for 250mg, and I ask her what is the status right now, and she said it' a "go far status", so I ask her what does it mean "go far" status, she says it's the product in an advanced stage for approval, then I ask her point blank, when the product will be approved please, and she says end of May. She gives me her email address and ask me to send email if I have other questions, as the quality of the phone line is not so good. I google her name and find out that she is the Director of the Registration&Regulatory approval. Guys and girls, the Nicosan product is going to be approved latest of the end of the month. Stay tuned and GLTA
Posted by imakmony2005 on :
its coming.
Posted by BULListic on :
Sure looks like a lot of accumulation here at .012 today.
Posted by suncruiser on :
Bring on the approval were ready!
Posted by Johnwayne on :
This is where I am going to begin dumping profits, if I ever have any again. What is a good buy in price here. I know big news is coming.
Posted by J_U_ICE on :
I've been waiting a while with 2M shares
Posted by J_U_ICE on :
This is starting to raise some eyebrows rumor of drug launch by months end
Post from IHUB
Xechem Nigeria is currently working to equip the laboratories and complete the construction of its state of-the-art pharmaceutical manufacturing facility. Certain laboratory and other equipment necessary for the production of NICOSAN™ have been acquired or are in the process of fabrication and Xechem expects that the plant will be ready for full-scale production by 2006. Approximately $5 million has already been invested by Xechem in the Nigerian project to date in the form of inter-company loans. Upon completion, the Xechem Nigeria facility at SHESTCO will be one of the most modern state-of-the-art research, development and pharmaceutical test, analysis and manufacturing facilities in Nigeria.
Posted by topsail on :
Holding 750K shares. Avg price .016 I may try to pick up some more shares since I believe XKEM has a viable product and business plan, but I'm also leery of having too much into one stock.
IMO, I agree with prior sentiment the company is waiting for the drug to be approved and to also receive approval from the Nigerian government before releasing a PR.
GLTA
Posted by imakmony2005 on :
should go soon.
Posted by JimSC on :
Hope we get the great pr by the first week of June.
Posted by topsail on :
OK, I'm confused. Bid was at .011, ask .0117 Then all of a sudden Scotttrade shows 11 million shares trading at .0074
Did other sites show this? Any ideas?
Posted by BULListic on :
Had a Heart Attack myself, "lost" 3 grand there for a minute. My ScottradeElite was down (again) when that event happened, so can't tell if it was a reverse fat finger or something more sinister.
Posted by topsail on :
Actually it ended up being about 20 million shares at .0074 Gonna be interesting to see if something is up.
Posted by JimSC on :
Don't get panic. That sale was on AON.
0.0117 X 0.0118
Last sale: 0.0118
Posted by BULListic on :
Jim, what is your theory on that transaction? MM transfer, someone got caught in areal bad market order?
The silver lining in the cloud from the late filing is that biz in Nigeria must be "booming!"
"We have significantly expanded our operations in Nigeria over the past year. This factor has resulted in our requiring additional time and coordination in completing our disclosure. As a result of the foregoing reason, we will not, without unreasonable effort and expense, be able to complete our Form 10-QSB within the prescribed time period. The completed filing is expected to be available within the requested five day extension period."
Posted by hellars on :
How sure of a thing is the approval?
Posted by BULListic on :
Based on the size of the manufacturing plant in Nigeria, I'd say 99.999%
quote:Originally posted by hellars: How sure of a thing is the approval?
Posted by hellars on :
quote:Originally posted by BULListic: Based on the size of the manufacturing plant in Nigeria, I'd say 99.999%
quote:Originally posted by hellars: How sure of a thing is the approval?
And how much revenue and profits are we talking in the first couple years of production?
Posted by BULListic on :
That's the $64,000 question. This stock will go up significantly upon any approval news, profits and revenues won't really matter as is the case with most pharmaceutical companies in development. Your betting more on the news than you are on the profits IMO.
More on the drug: In July, 2002, Xechem acquired an exclusive, worldwide license to develop NICOSAN™ (HEMOXIN™ in the US) from the Nigerian government and, subsequently, received U.S. orphan drug status for HEMOXIN™ from the FDA in August, 2003. The product is made from four botanical species indigenous to Nigeria. NICOSAN™ is produced there today by Xechem. The Company expects to launch NICOSAN™ in Nigeria’s 4,000,000 SCD patient market, the world’s largest SCD market, in 2005. SCD, a devastating hereditary blood disorder characterized by acute painful crisis, organ damage, anemia and early death, affects over 80,000 African Americans in the U.S. alone. Based on published data and human experience, the Company believes the successful clinical development of HEMOXIN™ represents an unusually low risk. In phase II human studies in Nigeria, published in Phytomedecine, HEMOXIN™ was shown to be safe in all patients and effective in approximately 80% of patients. As published in the May 2003 issue of the British Journal of Hematology, Asakura and colleagues from Children’s Hospital of Philadelphia (CHOP) and the University of Pennsylvania demonstrated the anti-sickling effects of HEMOXIN™ in transgenic mice. This lends significant credibility to the Nigerian human experience to initiate clinical trials in the U.S.
quote:Originally posted by hellars:
quote:Originally posted by BULListic: Based on the size of the manufacturing plant in Nigeria, I'd say 99.999%
quote:Originally posted by hellars: How sure of a thing is the approval?
And how much revenue and profits are we talking in the first couple years of production?
Posted by JimSC on :
Based on the Nigeria project and drug approval, XKEM is a good gamble. The pps could be 5X to 10X in 6 months.
Posted by Brad C on :
All the info on the company and the drug is good this should take off by the end if the month....
Posted by BULListic on :
Same story as yesterday, all kinds of buys at .012 and fairly large ones at that. 90% buys again today. Come on Nigeria, throw us a bone Posted by JimSC on :
Hold on there, Bull. This is a waiting game. The good news will come in the next few weeks.
[ May 18, 2006, 11:52: Message edited by: JimSC ]
Posted by BULListic on :
Like clockwork, back to .011...this time about 27 minutes before yesterday
Well, because it's going back to .012 on strong buying again tomorrow, might as well pick up some more cheap shares down here
Jim, I'm a very patient guy....I've been waiting 98 years for the Cubs to get to a World Series Posted by J_U_ICE on :
Caught this on Raging Bull a lot of pub
Xechem International Inc, OTC BB:XKEM Date: May 18, 2006 This stock was mentioned in all the following reports between May 10 and May 17, 2006; 1)Plunkett's Biotech & Genetics Industry Almanac 2)Reuters Investment Profile 3)Plunkett's Biotech & Genetics Industry Trends & Statistics 4)ValuEngine Summary 5)Wright Reports 6)Weiss Ratings
Posted by hellars on :
I'll be gradually getting into this one over the next few days of trading.
Posted by Brad C on :
I'm in!! Come on good news I am ready to help give out meds. With all the volume we could see good numbers next week. "How much is a man willing to pay to make a penny"
Posted by J_U_ICE on :
Not a good day but volume keeps coming hopefully approval rumors are true. If so we should be sitting pretty within the next month
Posted by Johnwayne on :
Juice- 30% of my EQBM profit is going to be parked here. In fact 30% of every profit I make next week is going here. Good luck all.
Posted by J_U_ICE on :
quote:Originally posted by Johnwayne: Juice- 30% of my EQBM profit is going to be parked here. In fact 30% of every profit I make next week is going here. Good luck all.
I loaded up on this a couple months ago and have been holding waiting for the approval. This is going to be big IMO. The only "real" long term hold I have are XKEM BIGN VNBL and free shares of RSHN. That and throwing a few hundred at BS like PAIM SMMW
Posted by hellars on :
Someone mentioned this could get approval by the end of the month?
What evidence is there to assume that?
Posted by J_U_ICE on :
quote:Originally posted by hellars: Someone mentioned this could get approval by the end of the month?
What evidence is there to assume that?
It's mostly speculation. Most of which are posted throughout this thread and the PM I sent you read through this thread again. Here's one:
From RB, By: alexng00 15 May 2006, 12:58 PM EDT Msg. 31490 of 31685
In addition to the feedbacks provided by Steve Burg, I called directly NAFDAC organisation this morning to get other confirmation and updates. I pick up the phone number from the NAFDAC website and reach a person within NAFDAC who provides me another number of a responsible person,I call that person and I ask her about the submission from Xechem for Nicosan, she checks the system and confirms to me that Xechem has submitted the master drug file in March, she said they submitted the Nicosan product for 250mg, and I ask her what is the status right now, and she said it' a "go far status", so I ask her what does it mean "go far" status, she says it's the product in an advanced stage for approval, then I ask her point blank, when the product will be approved please, and she says end of May. She gives me her email address and ask me to send email if I have other questions, as the quality of the phone line is not so good. I google her name and find out that she is the Director of the Registration&Regulatory approval. Guys and girls, the Nicosan product is going to be approved latest of the end of the month. Stay tuned and GLTA
Posted by idreamer on :
XKEM comming up i like this stock it's so quite for a while but it will be up soon. good luck everybody.
Posted by Brad C on :
I hope we all do good on this one. Hold on tight!!!!!!
Posted by bond006 on :
With all the publicity and talk this should see green this week.
Posted by howied on :
ok, i have a question, and dont want to offend anyone. but where they are building there facilitie is in nigeria, how well do we trust that... i have been scammed bt nigerians in the past. and i was looking at all the pictures on people working there, and saw no americans(that i could tell), but i might be wrong.. i just wanted to point that out. and see what everyone else had to say about it.
Posted by howied on :
it also says in this 2004 article that this product would be on the market within 12 months.. back in 2004, it also says they are working in this in india..
(3) We are in negotiations with UPS Capital Business Credit to obtain financing in the sum of $8,253,000 for our pharmaceutical project in Nigeria. In March 2006, we paid a $50,000 non-refundable good faith deposit to UPS and the loan facility proposal is being processed under the U.S. Ex-Im Bank Loan Guarantee Program. One requirement, among others, of the loan facility is the provision of a Nigerian bank guarantee in the amount of the proposed loan, from an identified Nigerian-based bank.
Two Nigeria-based banks, have been identified which are qualified to provide the Nigerian bank guarantee required by UPS Capital and Ex-Im Bank. UPS has provided a loan offer to us, subject to our review and approval. The two Nigerian banks must also review, and approve the UPS offer. Upon the banks' acceptance of the loan offer, they will undergo discussions with UPS regarding the final terms. If UPS completes the negotiation to its satisfaction, a formal request will be submitted by UPS Capital to Ex-Im Bank for the credit guarantee approval. If Ex-Im Bank provides the loan guarantee, UPS Capital will be authorized to disburse the funds to us.
Posted by bond006 on :
this is interesting to
(7) It is anticipated that sales of our product NICOSAN(TM), a sickle cell drug, will commence in Nigeria in the second or third quarter of 2006. Initially, it is not anticipated that revenues will be significant but they should help in covering the costs of the operation.
We expect to continue our development efforts with respect to antifungal, anticancer, antiviral (including anti-AIDS) and anti-inflammatory compounds, as well as antiaging and memory enhancing compounds. Although we do not expect product revenues from these sources in 2006, we anticipate that these development activities may allow us to enter into more favorable licensing and/or investment arrangements.
Posted by howied on :
lets up it goes up soon
Posted by bond006 on :
I sort of exspected this dip when the form 10 came out you have to remember this stock is going to pay off on what people are thinking of what furture earnings will be
Posted by bond006 on :
Even if they started production to day they would not see profit until next year but shear investor spectulation would drive the pps up
Posted by BULListic on :
XKEM bouncing off a low of .0101 now 106x107 with a few buys....
Posted by howied on :
not bad right now at .0112
Posted by hellars on :
If the approval didn't happen how much do you think the stock would drop?
Posted by Brad C on :
It seems like the news on the production site and the drug has been tested in Nigerian and it worked on the people. It would seem the drug should be a go..
Posted by hellars on :
quote:Originally posted by Brad C: It seems like the news on the production site and the drug has been tested in Nigerian and it worked on the people. It would seem the drug should be a go..
You dodged the question =P...
Posted by bond006 on :
It would most likely drop to .005 I would say until some thing else could be worked out. And is just MHO based on stocks that don't meet there goals. Could be lower if no other plan emergers
Posted by J_U_ICE on :
up 5% today good volume
NEXIM’s initiative on sickle cell drug By Sun News Publishing Thursday, May 25, 2006
More Stories on this section The grant of N150 million facility by the Nigerian Export Import Bank (NEXIM) to Xechem- a local drug maker, for the commercial production and marketing of NICOSAN, a new herbal drug for the management of sickle cell disorder, is certainly a milestone of sorts for the heath care sector.
Milestone because for million of sufferers of the Sickle Cell Disease as well as carriers of the gene, it is the long awaited succour for a genetic ailment most pronounced on the continent, and for once, Nigeria is leading the world in finding a cure for a scourge for which her own citizens have the highest population of sufferers, possibly in the world.
With many products of research endeavours lying on the shelves of research bodies waiting for commercial exploitation, it is heart-warming that the National Institute of Pharmaceutical Research and Development (NIPRD), Xechem and NEXIM, have combined to deliver to Nigerians, and indeed the global health community, this unique solution in the management of the sickle cell condition.
We certainly know that the bane of research undertakings in the country is the lack of critical linkage between research and the manufacturing and the financial services sector with the result that research breakthroughs do not get to the marketplace due to lack of entrepreneurial interest. It is noteworthy that the case of this sickle cell drug is a marked departure. We commend NIPRD, NEXIM and the drug firm, Xechem, for this timely and exemplary collaboration; it is an affirmation of the unlimited possibilities in the Nigerian environment, giving the right kind of incentives.
What the development underscores is the need to encourage more indigenous drug firms to collaborate with the research institutes to deliver more gains to the Nigerian people in the area of development and commercialisation of findings. It is certainly not good enough that local drug firms have consigned themselves to being trading outposts for imported drugs with little or no local value added; even local raw materials, where available, are begging to be exploited for commercial use simply because imported substitutes are preferred.
We think that a package of incentives for drug manufacturing firms willing to undertake such ventures make eminent sense if the government is truly desirous of getting these firms to play the desired role of creating jobs and providing solutions to the health care services needs of the nation.
The NIPRD breakthrough in the sickle cell drug should be an eye opener on the need to equip, upgrade and fund our research institutes to enable them play their assigned roles in national development. Leaving them perennially in the throes of budgetary shortfalls is hardly the way to help them play these roles.
On their own part, the institutes themselves should explore opportunities for collaborative efforts with industry to attract funds and to ensure that important findings are not left to rot on the shelves. Now that NEXIM has shown the way in providing venture capital for the sickle cell drug, it behoves other financial institutions to support similar initiatives
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