Replies to post #57473 on NorthWest Biotherapeutics Inc (NWBO)

[AVII77]

NW stated the goings on back then were part of the trial protocol, and nothing untoward was occurring.

If this relates to changes for imaging procedures and analysis of images, that would not have happened in a vacuum. The resizing occurred in 2014. The new protocol may have anticipated changes in imaging standards, and the FDA would have been a part of conducting that eventual midtrial change.

The over riding principle is that any change must arise from information EXTERNAL to the trial.

To support that, any change is most often done PRIOR to any interim (to remove doubt of a "data-driven" change)

So, if they said: Gee, we should consider iRANO, or gee, we should consider only Mesenchymal patients, or if they said Gee, we should consider only patients with large amounts of TIL's in their resected tumor, then I suppose anything is possible. Just so long as all those changes are driven by external data. I truly do not see how they could change the assessment of prior patients by retroactively using iRANO; especially in a trial with x-over.

But none of these changes/scenarios explain why Kat can't get her DCVax through expanded access/compassionate use/UK-EAMS.

Do you have a theory that incorporates that data point?

That data point is most consistent with an FDA Partial Clinical Hold placed on the IND. Is that the only possible reason, I don't know. But I can't think of any other reasonable explanation. Can you?

On the flip side, it's hard to imagine they could be under an FDA partial hold and not be required to more clearly disclose it. here is a letter from the SEC to a small biotech telling them to clearly disclose their clinical hold. If their disclosure were misleading or incomplete one would think the SEC would have stepped in and sent a similar letter by now.

Truly another NWBO mystery.