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hnbadger1

11/20/25 12:55 PM

#509145 RE: Chemdeps #509143

I hope that Anavex management is busy contacting AD advocates and third party interests throughout Europe.
Apparently CHMP is interested in what they have to say.

CHMP meeting that will take place in December. Please note that third party interventions are considered by the CHMP in so far as they are relevant for an ongoing assessment.
Third party interventions are also shared with relevant applicant(s) as it could potentially affect the outcome of ongoing procedure(s) being assessed by the CHMP. This allows applicants to exercise their right of defence and fully understand the reasoning and conclusions reached by the CHMP, as applicable.
In this regard, please confirm you agree that your letter is shared with the relevant applicant in its current format, or, alternatively, propose a version which you would agree to be shared where any commercial confidential Information and/or personal data (e.g. name of the intervener) is redacted.
Kind regards,
Scientific Officer
Therapies for neurological and psychiatric disorders
Human Medicines Division
European Medicines Agency
Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
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BIOChecker4

11/20/25 12:59 PM

#509148 RE: Chemdeps #509143

Taking Missling at his word is foolish. He’s a fibber. We know what he said but we don’t know what the EMA actually told him.
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abew4me

11/20/25 2:09 PM

#509155 RE: Chemdeps #509143

You're asking the right question. Why was the EMA vote trending no?

Answer: The EMA votes almost always at the recommendation of CHMP.

Which begs the obvious question: Why did CHMP have a negative view of our data...and then convey that negative view to the EMA? (Especially with all of the meetings that took place between CHMP and our prestigious staff!)

I think the answer is pretty obvious.