Replies to post #366028 on NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

NWBio provided guidance that they received Buy-in from all 4 regulatory authorities.

But, they have to include any possible "Risks" disclaimers in the 10-K filing with the SEC.

I am sticking with the guidance they previously provided, until or unless they update or change their guidance.

[biosectinvestor]

Buy in is always conveyed by the FDA as non-objection, from the beginning to the end, but even if you get an agreement, signed by the FDA at the beginning of a trial, called an SPA (Special
Protocol Agreement), even then, they can change their mind if they decide, at the end, “You know what, those FDA guys who were here before, they were not us”.... They give no assurances that they know or will certainly do anything in the future. The risk is all on you...not them. They are not going to agree to anything that in advance that they later think, you know, we should not have agreed to that. So they never guarantee anything. Period.

[TopelRoad]

It’s not a gold standard double blind trial, so by traditional standards, this is not good. But the data may tell a strong story.

[iwasadiver]

It means they’re not going to say anything definitive. I’m going to say this: The RAs in the UK and in the EU changed the protocols on their websites. This is clearly saying they’ve bought into the idea. I believe the FDA did not respond, because they do not have to. An SAP does not have to be “approved” by the FDA. I am making the assumption they did not give it a thumbs down or tell them they didn’t think NWBO should approach the data in this manner (which I think they would have done if they thought the company was about to engage in a procedure/plan that the FDA was completely against). It’s implied in the world of clinical trials that if the FDA does not respond with criticism or rejection of things that they’re in agreement, or at least are not against it. If the FDA did not respond NWBO is not going to change the endpoints on clinical trials.gov. But it almost guarantees they’ve accepted the idea.

NWBO just came out and said definitively that they changed the end points because of Pseudo-Progression and the Crossover. This is significant because it means we’re at the final bell real soon, the cards are on the table and ready to be flipped over. I see UK approval quickly. EU following, then Canada. I may be surprised but I think the FDA is watching and waiting. I think they’re going to take an extended look and will be influenced by what the UK does specifically. They’re simply more clunky than the slimmed down and streamlined MHRA. But I believe Joe Biden is in their ear. I believe it completely.