Geo-- Cotara took unusually long because the Company proposed a trial design with no real control group other than historical data from other trials. The Phase III Cotara trial is randomized only in the sense that it compares two different doses of Cotara. This is extremely unusual and it took an unusually long time for the FDA to get their arms around Dr. Garnick's reasoning for this novel approach.
The text book time lines for EOP2 meetings are very likely to apply in the case of Bavi Phase III 2nd line NSCLC, where the Company is simply repeating (with a few more patients) the trial design of Bavi Phase IIb 2nd line NSCLC.
Plus, I heard from CK that "the FDA is being very cooperative." IMHO, this cooperation could translate into a Phase III trial design decision sooner than 60-90 days, but that's just my personal guess.
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