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CATTDOGG12347

10/16/17 7:15 PM

#38740 RE: DewDiligence #38738

Pretty sure it can be granted based on secondary endpoints which wouldn’t require a data readout (after 184 events, death or disease progression) if memory serves me correctly.

ignatiusrielly35

10/16/17 7:25 PM

#38750 RE: DewDiligence #38738

Dew, why is there no shorter pathway to AA for Aim2Cerv? Also, when you say "AIM2CERV will almost certainly take longer to read out for DFS (the primary endpoint) than IMDZ's trial will take to read out for PFS" do you have any idea what the SPA called for? Cannot the FDA decide to grant AA at any time that it becomes likely that the benefit outweighs the risk, for serious diseases?