Friday, September 26, 2025 7:16:18 PM
100% AGREE and I don't know why everyone (bulls and bears) is so dismissive of this theory.
It's literally the only theory that explains everything from the seemingly unexplainable never-ending MHRA "rapid review", to the fact that the MHRA keeps saying there is no backlog, to the fact that if there were major issues or unobtainable RFI's with the MAA, it would already have been rejected, to the fact that we are pretty much beyond the point where the delay can be explained by RFI's, and most importantly it matches what NWBO literally TOLD US in their latest 10Q:
"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.”
It also fits together nicely to the announcement of the Advent purchase NOW, the purchase timeline, and the associated PR which basically states that DCVAX will be approved.
Also it matches up with NWBO scheduling conferences (placeholders) for LP in the coming months.
Also it's congruent with previous NWBO milestones taking forever but never overdilevering.
Also, this explanation is soo much more likely than AI bulls pie in the sky secret manufacturing approval, tumor agnostic approval, or project ORBIS.
Also, this explanation is soo much more likely than paid FUDSTER's doom and goood theories of MHRA stealth rejections via "MAA purgatory" or needing to complete pediatric trials, or by requiring unobtainable patient level ECA data.
It's literally the only theory that explains everything from the seemingly unexplainable never-ending MHRA "rapid review", to the fact that the MHRA keeps saying there is no backlog, to the fact that if there were major issues or unobtainable RFI's with the MAA, it would already have been rejected, to the fact that we are pretty much beyond the point where the delay can be explained by RFI's, and most importantly it matches what NWBO literally TOLD US in their latest 10Q:
"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.”
It also fits together nicely to the announcement of the Advent purchase NOW, the purchase timeline, and the associated PR which basically states that DCVAX will be approved.
Also it matches up with NWBO scheduling conferences (placeholders) for LP in the coming months.
Also it's congruent with previous NWBO milestones taking forever but never overdilevering.
Also, this explanation is soo much more likely than AI bulls pie in the sky secret manufacturing approval, tumor agnostic approval, or project ORBIS.
Also, this explanation is soo much more likely than paid FUDSTER's doom and goood theories of MHRA stealth rejections via "MAA purgatory" or needing to complete pediatric trials, or by requiring unobtainable patient level ECA data.
Bullish
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