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davidal66

04/13/17 7:28 PM

#814 RE: memeil26 #813

I have to check my notes, but I believe the SPA was designed and powered to show a 2 month separation b/w the kaplan Meyer curves in overall survival at the completion of the trial. Take a look back at the SNO presentation and some of the earlier materials.

As to the FDA, I believe if they show this two month separation or better at trial's end, the drug will be approved based on the SPA. The better the drug functions, obviously, the better the profit margin will be... premium pricing for more survival, less pricing for less survival. If we get several complete responders/partial responders as contrasted to Avastin.... say 28 percent response rate versus 10 percent response rate for Avastin only as the phase II showed, this will be a meaningful secondary endpoint.