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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Jon Khymn who wrote (31351)	5/30/2009 10:31:01 AM
From: Dave O.	Read Replies (2) \| Respond to of 52153

I think it was 6 deaths, not 8. And there were deaths in the placebo arm of the study. Realize that 84% of those in the Phase 3 trial had pre-existing cardiovascular problems so one would expect this rather sickly group to have cardiovascular events. And those who had cardiovascular events during the study were treated and continued in the study with no further adverse events. I listened to a conference call where they detailed the patients who had SAE's and the average age was 66. Dave

To: Jon Khymn who wrote (31351)	5/30/2009 10:52:48 AM
From: Biomaven	Read Replies (1) \| Respond to of 52153

You should be aware that there will likely be movement in the stock when the FDA releases their briefing documents a few days before the advisory committee meeting. These documents give the FDA's take on the data, which is sometimes very different than the company's spin. In this particular case there will also be volatility associated with the panel discussion - this is an example of a drug where there is going to be a judgment made about the balance of risk and reward and so it will be hard to predict the outcome even once we see the briefing documents. Personally I believe this is the sort of choice that should be left to the patient and his (not many "hers" here I suspect) doctor. Plaster the label with black boxs, require a risk management program (perhaps even requiring explicit counseling for the patient) and approve the drug would be what I would say if I were on the panel. Peter