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Re: beartrap12 post# 287734

Saturday, 06/06/2020 3:43:53 PM

Saturday, June 06, 2020 3:43:53 PM

Post# of 687144
There are no new regs.

The guidence, when issued, is an explanation of how the FDA has been reviewing drugs. Nothing changes with it.

The SAP is a total unknown. In theory, if just a SAP it does not change the trial endpoints. But NWBO is free to write whatever they want in it.

If the data they know of indicated all was good with no problem, why are they trying to create an issue by changing the SAP and creating new sub analysis? Why do they want to redefine PFS if it is as incredibly beneficial on the original results as alphapuppy asserts?
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