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Biotech / Medical : VD's Model Portfolio & Discussion Thread

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To: Miljenko Zuanic who wrote (9532)	2/3/2003 2:37:07 AM
From: Vector1	Read Replies (1) of 9719

MZ <<What they do is that they are messing around like blind rats. >> LOL. Some analysts are clearly better than others. Since the analyst community is split on MLNM it is hard to lump them together. Following their reports blindly is an invitation to loose money. However, some provide very useful information. <<Or maybe MLNM is blind and stupidly, like IMCL, playing with FDA? >> I do not think MLNM management is stupid. Like you say I think they are taking a calculated risk. I agree, the downside is they have to finish the phase III which should be around the end of the summer and then refile at the end of the year. One of the things I learned from reading the CRXA/bexxar FDA briefing materials and listening to the advisory committee proceedings is that quality of data and quality of documentation of data is very important to the FDA. How were assesments of patients prior condition documented. The FDA looks for a very clear paper trail and in many phase IIs the rigor is simply not there. I am not saying that is the case here. I just don't know. <<Irresa and Erbitux can only dream >> I totally agree that Velcade is more effective in MM that Iressa and Erbitux is in lung cancer. <<That is incorrect. 7% discontinue from drug adverse events. 14% discontinue from disease comorbidity factors, not related to drug.>> I did not realize that. What are your views on the incidence of nueropathy. Do you think it is caused by Velcade or a remnant of prior chemo regimes. I also agree that most effective cancer drugs unfortunately have severe side effects. Since you mentioned IDPH Rituxan is one of the least toxic I know of. Gleevec also is fairly benign. <<. IF they have strong data, and I do believe that they do, why not ask for approval?>> I agree with you. We only disagree as to whether there is a significant chance they wont get approval based on the phase II. I think there is little risk the drug will not ultimately be approved. Time for me to go to sleep. v1

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