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rx7171

12/06/25 5:00 PM

#511004 RE: Good Ole Bill #510999

I have a hard time imagining someone who has made the effort to follow Blarcamasine’s development and its data including OLE then penning a note to the CHMP imploring them to reject an approval.
Shorts come to mind as the only possibility but what would be their argument that would carry any weight with people who are not stupid?
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baltimorebullet

12/06/25 5:11 PM

#511005 RE: Good Ole Bill #510999

I sincerely hope you're right, but didn't the company state in a PR that after the Dec. no vote they would file for re-examination?
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skitahoe

12/06/25 5:42 PM

#511007 RE: Good Ole Bill #510999

Bill,

I don't believe it's possible to ignore something new you learn from one time to another. If those making the judgement have been exposed to new, more positive information, I don't see how it's ignored.

As I understand it, the panel wasn't near unanimous in saying no, so nowhere near all voting no need to change their minds. As I understand it, those meeting in December won't be all the same people who met in November, but I'd have to believe that many would be the same. All will no doubt see what the prior panel determined, but if they're subject matter experts, I don't see how they wouldn't know about information not contained in the filing, and if they know about it, I don't believe they'll ignore what they know.

Gary
Bullish
Bullish