Replies to post #767606 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Bunkum. If you knew the history of this trial as well as you pretend to know, you would know that it was, as has been pointed out ad-nauseum on this board, the FDA that required control arm patients to be crossed over to the treatment arm when they progressed, thus introducing the confoundment that you decry. So, it was not introduced by NWBIO but effectively by the FDA.

A) The JAMA paper says otherwise. The crossover was allowed based on it being a carrot for enrollment. Are you saying the 72 authors lied in that paper or what?

B) That design in question was for a small P2 not designed to demonstrate OS efficacy. That NWBO repuposed the trial into a P3 then changed OS to the primary was on them.

[iclight]

Wow. Total bullshit. Seems as if you are the one that is full of Bunkum.

The conspiracy that someone at the FDA is against NWBO is bullshit. NWBO has time and time again failed to create a clear, logical, well run trial for DCVax-L. They morphed the P2 to a P3 because LP said it would be faster. How'd that work out?

They changed endpoints after they knew the original failed. The FDA did not approve the endpoint change. They simply did not reject it because it's a valid endpoint. That says nothing about NWBOs lack of ability to prove efficacy of this trial. What FDA does require is patient level data for an external control arm which Medicenna clearly stated after post P2 meetings with the FDA. They disclosed this because they aren't shady AF like NWBO. And that's why there is no BLA. LP can milk this MHRA bullshit for a long time so retail can buy more dead lotto ticket shares.