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Biotech / Medical : VD's Model Portfolio & Discussion Thread -- Ignore unavailable to you. Want to Upgrade?

To: Miljenko Zuanic who wrote (9529)	2/2/2003 11:12:22 PM
From: Vector1	Read Replies (1) \| Respond to of 9719

MZ, although I don't have your scientific background I did my due diligence on Velacade. In addition to reading the same abstracts you have I have read all of the major analyst reports discussing Velcade. The two best are a 25 page report on MLNM by CIBC outlining all of the Velcade trial protocals and results and a Jan. 27 report from SSB entitled "Is Velcade a threat to Thalomid". In addition I have shared my views with a few buy side managers who I respect. Lets be clear, I did not say Velcade is ineffective or will not be approved. I believe it is effective and that it will ultimately be approved. However, the FDA has made it clear that it is very uncomfortable with approvals based on uncontrolled phase II trials; even in the oncology area. To suggest that this drug has a 99% likelihood of approval based on uncontrolled phase II data is a judgement that I do not share. Yes, Velcade showed clear positive results in patients who failed Thalomid; I would expect it would since it has a different mechanism of action. However, 21% of patients had to discontinue taking the drug becasuse of an adverse safety event. In addition I have not seen any discussion on the quality of the data or the design of the trial. I did not hear MLNM say in their conference call that they had discussions with the FDA prior to the phase II Velcade trial indicating that they may use the trial for approval. In addition, when you compare the results of Thalomid, Revimid and Velcade in refractory patients the results are very comparable with imo Velcade showing more toxicity than Revimid. My point, however, is not whether Revimid or Velcade is the superior drug. Rather I beleive the FDA will hold MLNM to a very high standard for approval given the lack of a controlled phase II trial. Success at this point on MLNMs stragtey is far from guaranteed. That is why the stock is trading at below $8 per share. Most professional investors believe MLNMs Velcade strategy has significant risk. MZ we may disagree but I respect your opinion. I don't suggest that because we disagree your opinion is uneducated. I would hope I would get the same respect from you. v1