Replies to post #757117 on NorthWest Biotherapeutics Inc (NWBO)

[NotSure2]

The opposite... But even if aproved, it can take a long time, if looking at statistics, NWBO should fall in the longest due to "no precedent", (LP's words), complicated process, old trial in lots of different locations, small staff, etc....

End of 2025 or beggining of 2026 possible.

[skitahoe]

BI, while I believe you'll be break even or better with approval, if you can afford it, I'd suggest adding shares at these bargain basement prices and bringing your break even down to perhaps the $.70 range where approval should make you profitable.

Gary

[flipper44]

Slowness is not typically a “tell” of success or failure, because rejections are not announced by the MHRA.

Thus far, however, it seems NWBO and the MHRA have, in their own way, taken pains to inform people this is still an active/progressing MAA. So, because of that favor, you are not wrong. A

Patients wait.

[KRISGO]

I see lots of comments on here both positive and negative but my thoughts are that if the MHRA has reason to not approve DC-Vax then surely they would have found it by now and the respective announcement would have been made. Isn't the fact that it taking so long a good sign or am I just clutching at straws?

Good question, and I asked the same thing a few months ago but didn’t get a clear answer because, it seems, no one really knows. It looks like MHRA doesn’t set a specific date to notify companies about their decision. Instead, they put the approval on hold, either requesting more information or staying silent without providing any updates. I’m not sure why.
In our case, we've been hearing some news (rumors/leaks), some from people who recently spoke with management. Initially, most of us thought our second CHM date was in December 2024, with a decision expected by the end of January 2025. Then, in January, we learned that some last-minute inspections occurred in the last week of January, pushing the decision to likely the end of February. By the third week of February, we heard about another inspection, so the decision was expected by the end of March. Since February, however, we haven’t heard anything about further inspections or updates. If the decision doesn’t come in the next few weeks or by the end of April 2025, we may have to assume there’s an issue and that MHRA is hesitant to approve it. Let’s see if we get any clues in the 10K next Monday, and I hope they release it without needing to file for an extension.