Replies to post #316075 on NorthWest Biotherapeutics Inc (NWBO)

[anders2211]

what I personally believe when it comes to the FDA buy in of the SAP is this.

1. It is material if the SAP/endpoints would have been denied by the FDA.

https://news.bloomberglaw.com/securities-law/insight-the-sec-fda-nexus-best-practices-for-publicly-traded-life-sciences-companies

since they have not PRed a denial it is my belief the same SAP has been accepted by the FDA either by silence after x FDA days revision passed as some suggested or a plain yes its accepted.

2. It would be incredibly risky to unblind if the SAP has not been bought in by the FDA. If the SAP needs to be adjusted then NWBO can be easily accused of post hoc data mining what has happened to Biogen and its Aducanumab recently.

I personally believe NWBO waited for the buy in of SAP/endpoints either in Europe and or with the FDA which could have contributed to the recent delay. But I do believe both are in and perhaps even Canada.

[biosectinvestor]

I think people misunderstand how this all works.

The FDA does not approve protocol changes like it never approved an IND, in the way that ordinary people think. You don’t get a letter or email approving your IND. after they stop asking questions, you proceed. it’s the same process for the SAP change. The only way you get a kind of tacit approval that they might later reneg on is to get an SPA, or special protocol assessment.

We’ve discussed this all before. None of this is a new topic.

The process is the same. You submit your documents, they ask questions, and there is a back and forth during a statutorily established period of time, but they always reserve the right to ultimately question your analysis and rationale of details related to the trial, no matter what, even when it was the initial plan. Agencies endeavor to be rational, and irrational acts can be challenged by administrative procedure and then through the courts. But generally speaking, there is no real difference with the changed SAP and the initial IND. it’s the same procedures for approval. And just because the EU published it, and it looks more like an “approval”, I expect if they determined by themselves or after consultation with another RA that something was not right, they’d act accordingly as well.

There is no disharmony to anticipate at this time. That is only inventing new things to tease out on bulletin boards.

This trial has followed an adaptive course before the SAP I believe, so to some degree that document in my opinion is consistent with how the process was encouraged to continue.