Replies to post #138864 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Remember that the term Catch-22 developed to describe situations created by the federal government.

But the FDA never required the P3 to have a crossover.

The FDA may have required crossover in a P2 that was never powered to show OS. As such, it had no harm. And PFS is a reasonable choice for primary endpoint in a P2, even if poor for the P3.

It was NWBO that elected to "repurpose" the P2 into a P3. The FDA allowed this, but in no way implied that it would become a suitable trial for approving the drug. NWBO could have elected a proper design at that time.

NWBO "repurposed" the P2 in order to save time. Les gloated about how they saved shareholders years and millions by this shortcut.

The result is:

. Never saved any time as they have had to expand the trial and go past the PFS endpoint anyway.

. Has a screwed up primary endpoint. Everybody is saying OS is a better choice, and this was known in 2012. The FDA does not like PFS as an aprovable endpoint in front lie glio. Even marzman says the FDA can not evaluate it in this setting.

. Has a confounded OS secondary endpoint.

. Has likely effectively cost more as the hold was most likely a result of the PFS endpoint in some way, and that has damaged the share price thus more dilution.

You used the wrong term (Catch 22). This trial is a self created Cluster F***.