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Biotech / Medical : Welcome to the POTP board, the DPP-IV company
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To: rareearth42 who wrote (13)8/4/2006 4:09:08 PM
From: former_pgs  Read Replies (1) of 90
 
>Correct me if I'm wrong but in the transcript, management specifically indicated they chose PFS as the primary outcome based on FDA guidance<

They stated that they designed the trials around PFS subsequent to the guidance published in 2005 by the FDA. Actually, that guidance is merely an exhaustive look at the various endpoints and the biases or potential problems associated with them. It does note, specifically, that the role of PFS to support licensing varies by cancer setting. I think this was recently shown by the Gemzar approval in ovarian cancer where the PFS data were sufficient. However, I'm at a loss to name a drug that was approved for NSCLC on the basis of PFS.

fwiw
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