Replies to post #501729 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

The "highly successful" P3 was very likely

Let me get this right. 2 GBM trials in last decade.

Trial A)

IA results presented to FDA and they agree with an early halt based on efficacy. Approval followed about a years later.

Trial B)

IA supposed to happen per sponsor. For unknown reasons FDA issues partial hold. 7 years later still no submission of any BLA/MAA

Odd that B is "highly successful" while A is a failure.

[HyGro]

Of course you left out the confounding and the "highly successful" was another posters comment, certainly not mine.

This trial is a mess and has so many biases that I highly doubt FDA will buy it. Cherry picking data, like adding the small recurrent GBM arm is epitome of data dredging -- wasn't in the original trial and was ginned up after the data was unblinded when they needed some positive news. It is only 64 patients, no prior DCVax-L rGBM trial and not a planned protocol -- only data dredged.