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Just a few months ago IDMI more than trippled before the FDA news....I think this time it should at least hit $5 again.....It could be a steal at these prices....
.....Most import Advice is to sell before the decision to protect any gain!!!!!
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I did a little DD for the boss who plays options with these fda approval plays, not much but I have no problems sharing it.
One topic to think about is that many believe that the FDA is taking kickbacks from larger drug companies to approve their drugs and not the small guys.
Notes: June 21st, IDMI obtained definitive agreements from investors to purchase approximately 7.1 million shares of its common stock. Under the terms of the offering, IDM will also issue five-year warrants to purchase an aggregate of approximately 2.4 million additional shares of IDM's common stock at an exercise price of $4.06 per share. The shares of common stock and warrants will be purchased at the negotiated price of $3.50 per unit. The closing of the transaction is expected to take place on or about June 25, 2007, subject to the satisfaction of customary closing conditions.
February 21, 2007: IMD Pharma Raises $12.8 Million in Private Placement. Approximately 4.5 million shares * $2.82 share. In addition, 782,500 additional shares * $3.243 share. Participants included both new investors, led by Palo Alto Investors, as well as existing investor, Alta Partners.
Palo Alto Investors is IDM's current largest share holder: 3.15 million shares, all new shares bought in February, 2007. IDM is Palo Alto's 33rd largest holding at $13 million as of June 21, 2007.
Palo Alto has two MD's and one PhD as research professionals in-house.
5/29/07 IDMI announced that Tim P. Wablert has joined the Company as President and CEO, replacing Jean-Loup Romet-Lemonne, M.D. Walbert joins IDM Pharma from NeoPharm, Inc. Mr. Walbert was at Abbott where he served as Divisional Vice President of Global Cardiovascular Marketing and Divisional Vice President and General Manager of Abbott Immunology.
Under his leadership, he helped Abbott Immunology to successfully obtain approval, launch and commercializtion of HUMIRA for the treatment of rheumatoid arthritis in the United State, Europe and other conuntries.
2. Pamela Bassett, the Cantor Fitzgerald analyst, "We view Junovan as a PRODUCT PLATFORM with potential to become a broadly used immunotherapeutic to treat metastatic disease in multiple cancers, a substantial unmet clinical need." May 25, 2007.
Yahoo message board rumors: take it for what it’s worth “IDMI is tight-lipped about the whole deal with Junovan. I attended the SHM eariler this month in Irvine (near Cortex) and the new CEO was quite bullish on getting the FDA to reverse, although he refused to say what measures they were taking. The results of the pIII trial generated p values suggesting efficacy for Junovan. The scuttlebutt is that the submission to the FDA was missing a form that caused the FDA not to review a portion of the data – the consequence of which the p values were not verified. The FDA turned down IDMI, but apparently gave IDMI an opportunity to set things straight and a re-review will occur with the final decision on August 26.”
My thoughts: This is a very interesting play that may be worth some extra research and time. The stock was trading near $10 when Junovan approvable seemed likely. After the FDA advisory board shot down the drug 12-2, the stock fell. Financing has been complete so even without Junovan approval the company should be viable and be able to develop their other products that have value in their pipeline. Potential upside on approval is high and I believe the share price is trading as if Junovan was rejected completely by the FDA. It is near its 52 week lows and Osteosarcoma does not have many effective treatment options. Also Junovan may have added value with a possible European approval.
-------------------- Disclaimer: Not accountable for anything I say
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No problem it was brief DD, but DD none the less. I have no cash to buy in this, otherwise I'd buy in as well especially since I think european approval is on the horizon. This will be my next buy in if any cash becomes available, but i think ill be tied up for a while.
-------------------- Disclaimer: Not accountable for anything I say
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I decided to buy some shares to sit on. I will hold for a while and possibly add more. If the price goes past $2.22 then I will most likely change my mind.
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quote:Originally posted by Pillzilla: Ace what is your exit goal for this one. I am on now.
Nothing specific...I would take anything over $4 but would love over $5. It all depends on how much Momo it gets, and what PR's or opinion articles come out...Good or Bad!!!
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IDM Pharma Announces Plans to Amend New Drug Application for Mifamurtide (L-MTP-PE) for the Treatment of Patients with Osteosarcoma
Monday July 23, 7:00 am ET
-Company to provide additional data, including updated Phase 3 survival data-
IRVINE, Calif., July 23 /PRNewswire-FirstCall/ -- IDM Pharma, Inc. (Nasdaq: IDMI - News) announced today that it has recently met with the U.S. Food and Drug Administration (FDA) and informed the FDA that the Company intends to take immediate action to supplement the data in its current New Drug Application (NDA) for mifamurtide (L-MTP-PE), formerly known as Junovan, which is being reviewed for the treatment of children and adolescents with non-metastatic osteosarcoma.
The Company plans to collect and submit additional Phase 3 data that will support the benefit of L-MTP-PE in the treatment of non-metastatic osteosarcoma. Specifically, the Company will continue working with the cooperative groups and investigative sites involved in the study to collect vital status (information on whether the subjects remain alive or have died) on patients who participated in the Phase 3 clinical trial and for which data was not available at the time of filing of the NDA in October 2006. When the additional follow up data have been collected, the Company will analyze the data set and expects to submit an amendment to the NDA to the FDA by the first quarter of 2008. In addition to collecting supplemental Phase 3 data, the Company is also working on addressing other concerns raised at the Oncologic Drugs Advisory Committee (ODAC) meeting held in May 2007 and discussed in the recent meeting with the FDA.
"While we believe the overall survival benefit of L-MTP-PE has been demonstrated, we acknowledge the issues raised by the FDA's review of our NDA, in part based on the submitted data set," said Timothy P. Walbert, President and Chief Executive Officer of IDM Pharma, Inc. "We are confident that these efforts will allow a more robust analysis of L-MTP-PE, will continue to support its overall survival benefit in osteosarcoma and will provide substantial evidence for the potential regulatory approval of this important treatment."
L-MTP-PE stimulates the innate immune system, or the body's first line of defense, to kill tumor cells, and based on data from clinical studies, when used in combination with surgery and chemotherapy, L-MTP-PE reduces the risk of recurrence of osteosarcoma and improves long term survival.
About the mifamurtide (L-MTP-PE) NDA
The L-MTP-PE NDA includes efficacy and safety data from 678 patients with non-metastatic resectable osteosarcoma, 332 of whom received L-MTP-PE, and from 115 patients with metastatic or unresectable osteosarcoma, 39 of whom received L-MTP-PE, in the controlled Phase 3 trial conducted by the Pediatric Oncology Group (POG) and the Children's Cancer Group (CCG), now the Children's Oncology Group (COG), sponsored by the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute. Also included are safety and efficacy data from 51 patients with metastatic osteosarcoma treated in earlier Phase 2 studies. The biological effects and safety of L-MTP-PE are further supported by data from 15 other Phase 1 and 2 clinical studies in which an additional 197 patients received at least one dose of L-MTP-PE.
L-MTP-PE stimulates the innate immune system (the body's first line of defense) to kill tumor cells. When administered in combination with chemotherapy and after tumor resection to osteosarcoma patients in the Phase 3 trial, L-MTP-PE provided a significant improvement in Disease Free Survival (DFS) (p = 0.0245) and Overall Survival (OS) (p = 0.0183). At 6 years, the probability of survival when L-MTP-PE is combined with adjuvant chemotherapy is 77% (95%CI: 72-83%) compared to 66% (95%CI: 59-73%) without L-MTP-PE, a clinically meaningful finding in a pediatric population where the longer the survival, the greater the chance the patient is cured of cancer.
Treatment with L-MTP-PE was generally well tolerated in all phases of study. Adverse events were mild to moderate in severity and included chills, fever, nausea, vomiting, myalgia, headache, tachycardia (fast heart rate), hypo- and hypertension, fatigue and shortness of breath, all of which are consistent events with the activation of monocytes and macrophages by L-MTP-PE and the flu-like symptoms that follow cytokine release.
The NDA for L-MTP-PE was submitted to the FDA in October 2006 and was accepted on December 26, 2006. L-MTP-PE was granted orphan drug status in the United States in 2001.
The FDA's ODAC voted 12 to 2 that the data in the NDA do not provide substantial evidence of effectiveness of L-MTP-PE in the treatment of patients with non-metastatic, resectable osteosarcoma receiving combination chemotherapy. The FDA will consider ODAC's recommendation when reviewing the NDA for L-MTP-PE. The Company anticipates a decision in late August 2007.
IDM Pharma is also seeking approval from the European Medicines Agency (EMEA) for the use of L-MTP-PE, or MEPACT as it is known in Europe. The Marketing Authorization Application (MAA) for L-MTP-PE was submitted to the EMEA on November 1, 2006 and accepted for review on November 27, 2006. The EMEA application is currently under review and the Company continues to work closely with the regulatory body to ensure they have the information needed to approve what would be the first new treatment option for osteosarcoma in nearly 20 years. L-MTP-PE was granted orphan drug status in Europe in 2004.
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I'm onboard still as well....still big upside potential. Just bought in way to soon apparently. Averaging down is not my style....but it is at 52 week low now.
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