NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

How could MAA be rejected? This is no such possibility.

. The P3 trial randomized 233 to -L and 99 to placebo. The trial's designed primary endpoint failed badly and the OS secondary almost certainly did.
. After an efficacy IA that informed them that the trial was sucking they changed plans.
. They waited for OS between the arms to save the trial, but that failed.
. The change to ECA was post hoc as they already knew key information about endpoints even though the trial was still blinded.
. The ECA was not designed prior to commencing the trial as the FDA says in their guidance.
. The ECA does not have patient level data as the FDA calls for in regulations
, The bias introduced by extent of resection is a serious issue and they have no data to adjust for this.
. CMC can be challenging as the trial spanned decades and the proposed facility was not used in the trial. GMP is not sufficient, one must have equivalent process.

There others. I thought the O'Brien Flemming adjustment for the IA when the FA was a completely different dataset was comical. And who knows how much is unknown.

Anybody who thinks there is little to no risk is seriously delusional.