NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

I have also generally believed the same ATL, that The FDA likely made the suggestions re external data, likely from consultations. I believe that the issue was an ethical one in regards to the control group, and also a cross jurisdictional regulatory issue that the Germans likely initially raised in terms of the ethics of the control arm. I believe they also likely were taking the FDA's suggestions regarding external control arms but I also seem to be finding that the FDA is behind the UK on implementing new reforms intended to make a lot of this much easier and in fact the MHRA seems a bit ahead on using real world data, in terms of final guidelines and finalizing their external data guidelines.

But I agree that the FDA is their primary regulator and likely all of their efforts to change things broadly have come directly from discussions with the FDA. That is my experience in a global context where multiple national regulatory agencies are involved and the largest market and biggest regulatory hurdles are in the US for reaching a given market.

That totally makes sense to me. The company seems to be giving lots of hints though to others, I do not typically talk to anyone because I think it can blur clear vision on my investments, but the hints seem to suggest that they may go with UK first. Certainly situating their manufacturing there and focusing as much as they are on the compassionate use program, it is suggestive.

But my general view, absent consideration of what people are telling us that the company is saying, and my recent review of UK regulation (which was quite favorable), would be that the FDA would be the primary regulator and focus for a company in NWBO's circumstances. But the new reforms plug in even at MHRA into Project Orbis, and extend the approvals even beyond Project Orbias via the UK's relationships. So it will be interesting to see where the focus and where it all is going right now. The potential there in the UK, if results are as many of us expect and hope, is for potentially very fast approval, and hopefully the same is true for the FDA.

All IMHO. Not advice, just my own opinions.