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


To: tom pope who wrote (19414)3/22/2006 1:21:19 PM
From: nigel bates  Respond to of 52153
 
Downgrade to Sell on Flawed Studies...

Report reads like a prior conclusion in search of a justification.



To: tom pope who wrote (19414)3/22/2006 4:08:53 PM
From: Biomaven  Read Replies (1) | Respond to of 52153
 
It is true that the recent FDA panel recommended against Gemzar becuase they were concerned that progression-free survival in reecurrent ovarian was not a good end-point. But there were a number of factors at play there. Here's one quote from a report of the meeting:

This increased risk of toxicity has led the FDA's Oncologic Drugs Advisory Committee (ODAC) to conclude that an increase in progression-free survival alongside increased toxicity without improving overall survival was not sufficient grounds for approval.

Note that the PFS increase was pretty modest (2 months) when set against the increased tox.

Note there is an upcoming AC meeting on endpoints in ovarian cancer.

Peter