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


To: BulbaMan who wrote (9145)9/16/2003 10:36:34 PM
From: Miljenko Zuanic  Read Replies (1) | Respond to of 52153
 
Because they have to.

IF MST for Deca was ~6 months by now they will have clear data for ALL pts. Event time was 91/2 months, but now looks as too short for complete analysis.

BTW, who is (and how much in combined decision-making) responsible for US NDA?

Miljenko



To: BulbaMan who wrote (9145)9/17/2003 9:30:25 AM
From: Biomaven  Respond to of 52153
 
Anyone have a clue as to why Genta/Aventis highlighted the confusing, combined data for all 771 patients?

Because that was the pre-determined endpoint of the trial. Likely it should not have been, particularly after they added more patients later than originally planned.

as the benefits of Genasense were never expected to show up until after 6-8 months elapsed.
They didn't know this ahead of time. Remember that's a median expected survival - half the patients die before that mark. If the drug worked dramatically then virtually all the patients that died would have been on the placebo and they could easily have achieved significance in this time frame.

Has anyone asked the company for the Kaplan-Meier curves they presented at the analyst meeting?

Peter