NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

The company did indicate that they would proceed with data lock when all 4 agencies accepted it. The SAP as far as I can see, is consistent with the policy aims of the FDA for trials exactly like this one.

I believe all 4 have accepted the SAP, but the FDA has policies that they are implementing that are all about advanced and adaptive trials for biologics like this, pursuant to the 21st Century Cures Act that are still in the process of being implemented and likely, given the many changes at the agency and the almost complete focus on the pandemic and challenges with the pandemic, the FDA seems to be moving quite slowly. Things that they have had in draft form for very long, and for which long ago they received comments, are still waiting to be made final policy and fully actionable. I'd actually wish the opposite were the case, given how many trials are on pause because of the pandemic, and there are very many, that the agency would therefore be using its staff in various efforts to get ahead on these many initiatives, but the reality is, they are out front on many issues, establishing thought leadership discussion, for instance on historical data related matters, and given the focus from all of the partner entities and the disruption of the pandemic, it just seems that the FDA's efforts are still going quite slowly. That is all IMHO.

That doesn't mean that it all won't come together at once, NWBO is perfectly situated IMHO when that occurs, but it does mean that the FDA while looking to be a good partner with innovative companies exactly like NWBO, is still a very bureaucratic place.