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skitahoe

12/06/25 8:05 PM

#511013 RE: baltimorebullet #511012

I'm no expert, but isn't the CHMP like the advisory committees the FDA uses? If so, didn't the FDA completely ignore a negative advisory committee report on an Alzheimer's drug that was nearly unanimously against the product. If the CHMP doesn't change their mind, couldn't the EMA do the same if it chooses to.

I'm not suggesting this will happen, just asking if it isn't a possibility, especially if the CHMP is nowhere near unanimous in their view of the drug.

What's sad is that if the CHMP had all the facts I believe they'd be nearly unanimous for approval. If an appeal is required, I believe that's where they'll end up.

Gary
Bullish
Bullish