NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

in no way did I mean to imply that they will attempt to remove the crossover and revamp Ph 3

Sorry, I misread your post.

If what we are talking about is just the alpha allocation to OS, then that is obviously different from what I incorrectly replied to over there.

The FDA should not have a big problem with NWBO changing the stat plan as far as allowing the trial to continue. It is certainly not harming patients to make this change. They would need to show power calcs, but these can be reverse engineered to show whatever they want.

This does not mean that allowing the change implies the FDA would accept the changed endpoint in a BLA, that is a separate issue. And the FDA will not give them a firm handshake on such.

But they could ask for a SPA to go along with the change. And that might have been hoped for in the time frame LP stated, but could easily drag on for many months.

The more I discuss the issue, the more I am convinced that I, you, Pyr, flipper and the rest are just reading tea leaves and nobody will nail the actual reason.