Replies to post #787367 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Randomized double blind trials with PFS as the main endpoint with OS follow up as 2nd endpoint are the GOLD STANDARD.

The GOLD STANDARD is a randomized trial with OS as the endpoint, And the NWBO -L P3 was not that.

A trial as you describe (and the NWBO designed -L P3) is/was very common, especially as a P2 with a hope for accelerated approval, It gives a chance for faster results while also a chance to prove OS.

OTOH, NWBO ran such a trial. But after finding out the trial as designed failed, they compared OS to summery data from other trials. Anybody with a clue in this space knows that is a JOKE.

[meirluc]

"and why the FDA sent them packing!".
Please submit the evidence that NWBO submitted to the FDA a BLA. that
was rejected. That would equal two material events (submission and rejection)
that NWBO would have been obligated to report to its shareholders.

Are you claiming that NWBO failed twice to report major material events to its
shareholders?