NorthWest Biotherapeutics Inc (NWBO): Gary, that is a good question. The FDA g...

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Re: skitahoe post# 359917

Saturday, 03/06/2021 12:07:15 PM

Saturday, March 06, 2021 12:07:15 PM

Gary, that is a good question. The FDA guidance regarding the RTOR clearly says that the new BLA process for a new oncology / cancer treatment can get started just with the top line data from the Phase II or III trial. Please see the excerpt from the FDA’s guidance below:

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