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manibiotech

09/23/25 3:01 PM

#789518 RE: attilathehunt #789516

Those are all reasonable scenarios .  Agree with your assumptions as opposed to some who claim here that approval has been in bag . 
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seekinganswers

09/23/25 3:14 PM

#789519 RE: attilathehunt #789516

Um, the trial failed! Everyone knows it ,...except you and a few others.
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AllSheWrote

09/23/25 3:18 PM

#789522 RE: attilathehunt #789516

Agree, this is a reasonable view. You would think it would behoove them to let the public owners (i.e., shareholders) know what is going on. But, alas, they have said very clearly they have no intention of telling shareholders anything.
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10baggerz

09/23/25 3:38 PM

#789527 RE: attilathehunt #789516

IMO they told us exactly what is going on at the very beginning of the latest 10Q, but for some reason only a few people here seem to be considering the most obvious reason for an extended delay without NWBO's DCVAX MAA being considered part of any MHRA backlog:

"Comments on Potential New MHRA Policies. In the UK, the MHRA issued a draft guidelines of IMPORTANT potential NEW POLICIES under which clinical trials WOULD be allowed to use external controls instead of within-study placebo arms, especially for severe or rare diseases, and the MHRA called for public comments during the second quarter. The Company worked together with physician collaborators, patient groups, statisticians, academics and political representatives to help mobilize public comments.”

There it is, straight from the horses mouth. I do believe the advent acquisition coincided with some assurance that NWBO had met all ECA guidelines. It's possible that MHRA will wait until the guidance is finalized before approving the MAA, since this is the FIRST MAA using an ECA so there may be legal reasons why the MAA needs to wait, even if the application has effectively been approved already.
Bullish
Bullish