this article is one year old. it demonstrates to me that the facility in abuja has been constructed with a great deal of xechem's input, and with a look towards FDA compliant standards for drug production and clinical trials. i'd say this puts worldwide sales of nicosan squarely in our sights, and may also be a huge benefit for FDA compliant trials of 5-HMF. here's one instance where an article that is a year old can be a lot more bullish than a brand new one.... this means we're ahead of the curve for international sales, because pandey was already planning on it. key text is in bold:
…As pharmaceutical companies risk sanction over GMP
The Punch Published: July 13 2005 Posted: July 13 2005
By Ibanga Isine
Any pharmaceutical company in the country that does not comply with current Good Manufacturing Practices in the production of drugs may soon face severe sanctions from regulatory agencies. The Minister of state for Health, Princess Olufunke Adedoyin, and the Director-General, National Institute for Pharmaceutical Research and Development, Dr. Ufford Inyang, said this in Abuja on Monday.
They spoke during the opening of a training programme on Good Manufacturing Practices for Pharmaceuticals and the Management of Clinical Trials organized by NIPRID in collaboration with Howard University of Pharmacy, Washington DC and Xechem Incorporated, both from United States.
They stressed the need for pharmaceutical and clinical research experts in the country to update their knowledge and skills in various stages of production of pharmaceutical products especially in the production, anti-retroviral drugs and artemisinin for malaria.
Adedoyin expressed gratitude to the Howard University and Xechem Incorporated for partnering with NIPRD to ensure that drug production in the country met the required international GMP. She disclosed that Xechem was currently building a local pharmaceutical manufacturing plant in Abuja for the production of NICOSAN, a drug for the management of sickle cell anaemia.
She said, “The manufacturing plant when complete will be GMP compliant and a United States Food and Drugs Administration approved facility.” Ufford advised pharmaceutical companies in the country to take advantage of the training programme to learn production of HIV/AIDS drugs.
He decried a situation in which clinical trials were not given appropriate attention by institutions offering pharmaceutical courses in the country, adding that the situation could prevent chances locally produced drugs from meeting international standard.
The President of Xechem Inc., Ramesh Pandey, said if pharmaceutical companies in Nigeria would compete with others at the international markets, they must comply with global guideline on drug manufacturing and clinical trials. He expressed thanked to the management of NAPRD and the Federal Ministry of Health for providing an enabling environment for drug development and manufacturing in Nigeria.
Source: The Punch, July 13, 2005 Pg: 44, BY: Ibanga Isine
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posted
Well this has been another tough day and i look at the tape we did not close strong. I think we are at a bottom or close if we test the .3's God forbbid it might be a collapse. I am not scared because the company now is stronger now and better than it ever has been. But I don't feel good either I look at my etrade account and I want to puke. But selling now IMHO is sellig at the bottom or close to it. I also think the mms can smell fear and they are not helping a bit. Lets all hope we can get a bounce tomarroow and get the momo going up again.
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quote:Originally posted by bond006: The pr that is supposed to come out has a lot to say that what people are talking about. i don't know but if it something that could have been said last thursday I wish they would have done it then and have kept the momo going
Some things that I am looking for in the next few PR's:
Expense of Drug to Patients Estimated Revenues How much they can currently produce Additional Loan Approval
posted
peaser what i fear is that they see how much volume has gone into xkem and have already decided that a registration of shares would raise them the loan, instead of paying it off themselves
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quote:Originally posted by bond006: Well this has been another tough day and i look at the tape we did not close strong. I think we are at a bottom or close if we test the .3's God forbbid it might be a collapse. I am not scared because the company now is stronger now and better than it ever has been. But I don't feel good either I look at my etrade account and I want to puke. But selling now IMHO is sellig at the bottom or close to it. I also think the mms can smell fear and they are not helping a bit. Lets all hope we can get a bounce tomarroow and get the momo going up again.
yup, close below 3s will be hard to overcome...a bounce off 32-35 is not out of the question, strictly TA junk... does *not* address PRs, financials, etc...
-------------------- Nashoba Holba Chepulechi Adventures in microcapitalism...
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posted
All this red, must mean a little green around the corner, I hope. Glad to see things back to where it should be. Have a good night everyone, and I hope for the best to all who have hung in there.
posted
It's been a depressing few days with Xechem. Not sure what a PR will do to this thing, seeing that a PR started this dowfall, heck maybe it will do the opposite of what happened last week.
Hopeful wishing, I know... but as I have said b4 I am in this for the long haul.
posted
I hope we get a PR, and it is 10 times what we could have expected. I think this company is legit and has a prosperous future, people just need to read it in a PR, I guess.
quote:Originally posted by cassity: I hope we get a PR, and it is 10 times what we could have expected. I think this company is legit and has a prosperous future, people just need to read it in a PR, I guess.
Cassity...I agree..but with the way things have gone the past week...it will take a while for anyone to get the "faith" back...and that may be the biggest problem...which is sad...
-------------------- #1 Rule: Protect your capital! #2 Rule: Never fall for the BS on the boards!
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quote:Originally posted by cassity: I hope we get a PR, and it is 10 times what we could have expected. I think this company is legit and has a prosperous future, people just need to read it in a PR, I guess.
Cassity...I agree..but with the way things have gone the past week...it will take a while for anyone to get the "faith" back...and that may be the biggest problem...which is sad...
I am assuming that he is just busy or tired of all the "stuff" that was going on....it got pretty crappy for a while...but hoefully after tomorrow..all will be fine...regardless of which way this turns...
-------------------- #1 Rule: Protect your capital! #2 Rule: Never fall for the BS on the boards!
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posted
With a few moments of thought, readers will quickly release this rumored news will be nothing substantial, most likely more fluff with lots of grandiose wording.
There are no sales, no revenues. The company is insolvent. No cash, loans beyond recovery.
What can this company announce which would be of a substantial nature? Nada.
Only news of a positive financial nature will have an effect; revenue generation, payment of loans, share buyback, dividends. Quite impossible for an insolvent company to announce anything of that nature.
This one "should" trade, majority volume, in the range of .045 to .049 tomorrow.
Only substantial news will up trend share price.
Fluff news might spur a brief rally as the gullible buy in or are fooled into buying.
Annoying grandiose fluff news might drive prices into a faster down trend.
I do not expect anything of worth.
Readers only need to think for a few moments on this to realize what is possible, and not.
Dr. Anumpa Chukushpa PhD MA BA FAI Choctaw Nation
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posted
Purl, thanks for the heads-up, but I am looking for a good PR, since you dont expect anything of value/importance that is better for those of us who do, one less flipper to worry about... P.S> prove their loans are beyond recovery, I laughed on that one.
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quote:Originally posted by mnvestor: Purl, thanks for the heads-up, but I am looking for a good PR, since you dont expect anything of value/importance that is better for those of us who do, one less flipper to worry about... P.S> prove their loans are beyond recovery, I laughed on that one.
posted
Cassity, there is no worthwhile potential for revenue in Nigeria. Almost all of the Sickle Cell victims cannot afford to buy this company product, in Nigeria.
Nigeria is rated the number two most corrupt country in the world. Bangladesh, I think, is number one. The Nigerian government could not be more corrupt.
One of the highest concentrations of poverty level peoples, are Nigerian.
Average life span is very low.
For XKEM to be successful in the long run, this company must generate substantial revenue. This will not happen in Nigeria.
Around the world, highly unlikely enough revenue will be generated to be of use. A large majority of Sickle Cell victims live in a state of poverty and their numbers are few; ten million estimate.
Those who are affluent, will seek professional level medical treatment in Western countries. These affluent people number very little, a rough guess might be a million of them.
Simply stated, there is not a viable base of revenue generation. XKEM might generate some revenues in two years, in five years, but this revenue will never be enough to amortize debt much less generate reportable profit. XKEM is too far in debt to recover.
I see nothing but red flags everywhere.
Some issues arise. Nigeria is completely corrupt; a gang of thugs. This give-away of XKEM product of late, is unethical, is immoral. Reasons for this is there have been no Phase III clinical trials to test if this product is effective over time, to test if this product is safe, to test if this product will exhibit harmful long term side-effects.
I am certain you are too young to remember a drug known as "thalidomide."
This pr stunt of giving this product to children is abhorrent. Pandey is using those children as a stunt to sell shares, and he is using those children as guinea pigs; he does not know what will be long term effects of his product. This is my personal opinion on this pr stunt.
Simple math will disclose the financial potential of this company. Outlook is very bleak.
My suggestion is to flip only while carefully protecting your capital until all of this pans out into something realistic and measurable.
I would not hold XKEM for more than one day.
Dr. Nashoba Holba PhD MA BA FAI Choctaw Nation
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you need to register to access this news service. I am a member
this is old also, but is posted to show that this medicine is in the pipeline of European Meds on the approval track. also to see it side by side with other meds in the 'orphan' stage.
International Approvals International Approvals: Nicosan/Hemoxin, Vigil, IPM Wound Gel
Yael Waknine
Yael Waknine
Oct. 25, 2005 — The European Medicine Evaluation Agency has approved orphan drug status for the phytomedicine niprisan in the treatment of sickle cell disease; Germany's Federal Institute for Drugs and Devices has approved modafinil tablets for the treatment of moderate to severe chronic shift work sleep disorder; and Costa Rica's Ministry of Health has approved a hyaluronic acid–based gel for the management of exuding or debrided wounds.
I am trying to access full article for copy here....Egg
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"Simple math will disclose the financial potential of this company. Outlook is very bleak."
Readers cannot calculate with any precision but rather can only rough estimate. There are no statistics available which disclose detailed financial condition of those who are Sickle Cell victims in Nigeria, other than an assumption they are extremely poor.
XKEM states four-million Sickle Cell victims.
Based on children per family, a rough guess is half of those four-million are children and not a source of revenue.
Currently, average is six children per family. If readers assume all of those parents can afford to buy the product, there will be roughly three-hundred-thirty-thousand parents who would purchase. Still, readers have to factor a percentage of those parents one or both might or will also be SCD victims suggesting very low income or no income.
Being very generous add the parent set to the remaining adult victims,
333,333 2,000,000
About 2.3 million, give or take whatever.
Should readers rough guesstimate how many of those people can afford the product, then numbers drop below a million. This is roughed out knowing average per capita income is about $650 per year; cannot afford the product.
I am being very generous. Assume XKEM does have one-million paying customers in Nigeria.
How much gross revenue will be generated?
How much will be costs of sells?
How much will be paid to the Nigerian government?
Upon realistic consideration, factoring in most are in remote areas unable to travel to retail outlets, many are under-employed or unemployed, tossing in all these socio-economic factors, it is impossible for XKEM to generate enough revenue, in Nigeria, to keep up with costs and amortize XKEM extreme debt.
Only solution to barely keep this company alive is heavy dilution, which is happening.
Again, realistic analysis of a revenue base points to very low gross revenue countered by very high costs and debt.
I, personally, am unable to develop any viable senario which suggests this company will become a viable worthwhile company, in the long run.
IMHO, there are many of us who are sitting on the sidelines licking our wounds, totally caught off guard by what happenned last week and re-evaluating the market forces involved here. Some of us are new to the cut-throat tactics and manuevers by entities seen and unseen.
Most of us have moved to Missouri, the 'Show Me State'. We still believe there is great potential here and that things are progressing over in Nigeria as the planned startup progresses. We are wary that something similar to 'July 5th' can happen again so are waiting to see real growth in production, sales, profits, etc., etc.
I do believe that XKEM will be back STRONG, but until this company is built up and able to flex it's muscles, it may start to slide sideways for awhile, from what level I don't have any idea. We are keeping a sharp eye on XKEM because we know that they have a great product. The next step is execution, how well they are able to create revenue and profit.
Hang in there, this may not be as easy as we had hoped for, but maybe down the road a ways the clouds will roll away.
Orphan Drug Niprisan (Nicosan/Hemoxin) for Sickle Cell Disease in EU
On Oct. 4, the European Medicine Evaluation Agency (EMEA) approved orphan drug status for the phytomedicine niprisan (Nicosan/Hemoxin, made by Xechem International, Inc.) for the treatment of sickle cell disease (SCD).
Niprisan is an ethanol/water extract of Piper guineenses seeds, Pterocapus osum stem, Eugenia caryophyllum fruit, and Sorghum bicolor leaves.
The approval was based in part on data from a phase 2b, placebo-controlled, double-blind crossover study in 82 Nigerian patients. The data showed that treatment with niprisan significantly reduced the frequency of SCD crises associated with severe pain during a six-month period (P < .01). Moreover, 73% of patients achieved complete remission. ------------------------------------------------- PLEASE NOTE THE FOLLOWING FROM ABOVE: Moreover, 73% of patients achieved complete remission. -------------------------------------------------
Niprisan did not appear to cause acute hepatic toxicity, as assessed by liver enzyme activity; evaluation of serum creatinine and blood urea nitrogen levels suggested that renal function also remained normal. No serious adverse events were reported.
Niprisan (Hemoxin) was previously granted orphan drug status for this indication by the U.S. Food and Drug Administration in August 2003.
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