Biotech Values

[hirogen]

I agree with you on a). But disagree on b) and thus c) with my interpretation of the timeline. I don't see it as the FDA having a shaky view of the interim results. My view is the same as Biomaven's - that when the FDA was made aware in Aug of the DMC recommendations, the FDA realized there would be 7-8 months of unconfounded data there for the analyzing. Why wouldn't the FDA want longer follow up data if available. My point in mentioning the 302 trial is that it would be inconsistent for the FDA to be so concerned about the 301 interim with it's p value <.00001 to demand a delay in crossover, but for the 302 interim with it's miss on OS to then allow it.

The other implication of your view is that the actual DMC recommendations likely occurred much earlier than Aug 2010 and at that time the FDA, JNJ, and DMC all agreed to withhold public release of the recommendations in order to delay crossover. Furthermore the timeline was then altered to reflect the Aug date of the "official" DMC recommendation in the FDA documents to better coincide with the final analysis (pre-crossover) cut off date.