NorthWest Biotherapeutics Inc (NWBO): They tried to get approved based on a P2...

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Re: exwannabe post# 585488

Friday, 04/14/2023 3:31:43 PM

Friday, April 14, 2023 3:31:43 PM

They tried to get approved based on a P2 that failed the primary endpoint of PFS but was stat sig on the secondary endpoint of OS. The FDA said that is no good and they needed a real P3 trial that properly defined the prospective OS endpoint in advance.

I think there have been a few changes in FDA's thinking since 2009.

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