Thursday, November 20, 2025 11:50:33 AM
We have laid out all the evidence for them over and over again, but they refuse to listen. We have told them that the company's trial manager conducted an efficacy IA on the trial in 2015 that almost certainly came back with a futility recommendation. This fact was denied by biosectinvestor even after the company finally acknowledged it in the top-line data report. The company should have scrapped the obviously flawed trial at that point and started over, but instead, they just decided to keep on going and not tell shareholders anything about what had transpired. Then, right before data lock and with knowledge of the efficacy IA, they post-hoc changed the endpoints on the trial and switched to external control groups instead of the trial's own control group (which showed placebo did better!). In doing this, they rendered the trial results scientifically invalid. The MHRA is a scientific organization and cannot approve trial results that are scientifically invalid. That's where we are. That is what we have told these folks for a long time now. But they refuse to listen. At this point, they are all trapped, and it's their own doing.
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