NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

Thanks,

I know what a SAP is I happen to know my way around FDA/NIH regs concerning submitting a SAP. I do not recall ever any biotech adding and editing their endpoints to the clinical trial website page without having it officially submitted to the FDA at the same time. Nope don't know any, perhaps someone else here knows any other biotech who did that?

Yes I know you cant do an IA without an SAP, but perhaps you should chance that you cant do any without one officially being submitted with the FDA. Cause there was a trial protocol (duh, you cant start an official FDA-certified medical trial without one) and there were apparently (un)?official endpoints (as still shown on the clinical website), BUT the latter... not officially submitted is that what you are saying?

Unless of course the endpoints as shown of the clinical trial website are submitted there without a plan to unblind the data and work towards those endpoints. If that is true then that is also unprecedented for a biotech.

It also goes through changes as the trial evolves

Like I said only with NWBO I have never heard of this ESPECIALLY when endpoints have been made public and is still made public as shown on the clinical website.

The whole story what happened in Cleveland etc I done quite follow.

I think with all due respect that its an incredibly strange story on how NWBO approached the SAP protocol over the years. And tbh I find it a bit misleading that what is showing on the government website was never the official plan.. (sorry)


Glad they submitted the one they have now as shown on the EMA website.