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AllSheWrote

11/17/25 9:17 AM

#798112 RE: 2B_unknown #798107

Always an excuse. You guys have a new one every week. All of the excuses you proffer are an effort to avoid confronting the truth. And the truth should be obvious to everyone because it's right in front of your faces. The company submitted trial results to the MHRA that are scientifically invalid. The company knows this, and it's the reason they chose not to submit the results to the FDA. That's why there is no news after almost two years since submission. It's over. And whether the MHRA has explicitly denied the application or not, they have made it perfectly clear to the company that the application is not getting approved as-is and will require major re-working of the data to fix the flaws. My guess is they have kindly suggested the company either submit the patient-level data from the study's own control group, or start over with a new trial. The company has not responded to this conundrum, because they know either option is a death sentence. Nor have they informed shareholders, because informing shareholders is not their style. They are going to ride this out and keep paying themselves as long as they can.
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hankmanhub

11/17/25 9:44 AM

#798121 RE: 2B_unknown #798107

but it's pretty clear that they didn't start the MAA review in earnest until about 8 months ago.


What is your source for this assertion?