Replies to post #389265 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

No, that is wrong.

It means asking the new question based on information from the trial.

NWBO had a ton of trial data for years. How many time has this message board said that the blended data makes it clear the new endpoints will be met? That alone would be post hoc if NWBO made the change based on the blended data.

And NWBO had far more data than just the summary we have seen.

The "we were blinded" firewall may work in court, not in science.

[biosectinvestor]

Exactly. Post hoc and data mining means looking at failed, unblinded data and then mining the other data for results.

The FDA specifically provides room for flexible trials and updates to SAP’s BEFORE unblinding, and considers those clearly as NOT post hoc and it’s not post hoc in fact.

In this case, driven by the scientific world’s change of a definition that MUST apply to this disease going forward for all approvals by the FDA and similar agencies, it would seem requisite and entirely appropriate for the FDA itself to inquire with regard to this redefinition and the company would need to have that data. That it helps potentially to show efficacy is completely irrelevant to the inquiry but not to ultimate approval. The FDA needs to ask that question and the company needs to be prepared to answer it. If it helps illustrate efficacy, then the FDA would necessarily take note. This could annoy some who think otherwise, but their logic simply can’t withstand appropriate, rational scrutiny in the context of rational drug regulation.