Replies to post #827300 on NorthWest Biotherapeutics Inc (NWBO)

[learningcurve2020]

So your thinking “the plan” was to submit a MAA to a tiny notoriously stingy regulator then let it sit in limbo until one day when that regulator eventually puts everything into place for a possible approval? And all without running additional trials?

[brooktrail1933]

What was the source of your comment "This morning I heard the MHRA rejected the application and NWBO is appealing"?
This is false. Rejection would require an 8K to inform investors. We have none.

[learningcurve2020]

That’s exactly why she said the Leuka operation would also be used for other business. You need to think like LP! SEC has no case.

“By opening this clinic, NWBO aims to alleviate capacity limitations and provide services not only for its own programs but also for external clients, potentially increasing revenue streams and operational efficiency.”

>>First off I think this idea of rejection and appeal is kind of crazy because of the April PR about the leukapheresis clinic. Putting that out while sitting on a rejection/appeal would be straight up misleading shareholders, which while definitely possible, is the kind of thing I think the SEC would actually care about a great deal. Also something that I think would leak.

[FrostyIsland3]

I too would like to know who said that the MHRA has already rejected DCVax-L's MAA and NWBO is now appealing that decision. I want to read their argument.

I am skeptical that something like this has happened. The CHM would have issued a CHM Letter on November 28, 2025 and NWBO would be required to disclose the existence of a CHJM Letter to the investing public in a Form 8-K. NWBO would be committing securities fraud if it failed to disclose the existence of a CHM Letter. Also, the MHRA would not bother issuing the investigational manufacturing license on December 8, 2025 and the full commercial manufacturing license on April 22, 2026 if there was a CHM Letter informing NWBO that the CHM was recommending rejection of the DCVax-L MAA. The MHRA probably would not be publicly answering Parliament that review is ongoing on December 8, 2025 and again on March 18, 2026 if there was a CHM Letter tentatively rejecting the DCVAx-L MAA.