Replies to post #313569 on Anavex Life Sciences Corp (AVXL)

[Bud Powell]

Is Dr. Patrizia Cavazzoni trustworthy as head of FDA? A shrink specializing in mood disorders. Apparently not much science going on (at least to a layman as myself) at the FDA under her leadership. I'd be curious to hear the Doc on this board express his opinion.

This episode covers the medical background of Dr. Patrizia Cavazzoni at the FDA. Her background is psychiatry and mood disorders, yet she is the FDAs Deputy Director for Operations at FDA’s Center for Drug Evaluation and Research (CDER).

Patricia Cavazzoni on Jeff Stephan show

we listened to the perspectives of the patient community, and we reviewed all relevant data. We ultimately decided to use the Accelerated Approval pathway—a pathway intended to provide earlier access to potentially valuable therapies for patients with serious diseases where there is an unmet need, and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit. In determining that the application met the requirements for Accelerated Approval, the Agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy.

https://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-new-treatment-alzheimers-disease" rel="nofollow" target="_blank" >https://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-new-treatment-alzheimers-disease[tag]FDA’s Decision to Approve New Treatment for Alzheimer’s Disease/tag]

[Bud Powell]

At bottom from last year. Is Dr. Patrizia Cavazzoni trustworthy as head of FDA?

This week ..

we listened to the perspectives of the patient community, and we reviewed all relevant data. We ultimately decided to use the Accelerated Approval pathway .... serious diseases where there is an unmet need, and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit. In determining that the application met the requirements for Accelerated Approval, the Agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy

"Expectation of clinical benefit" (according to ? ..) when not one from the expert panel out of 11 stated as such. That to me seems like a ... stretch, shall we say?

FDA decision to O.K. Aduhelm

A shrink specializing in mood disorders. Apparently not much science going on (at least to a layman as myself) at the FDA under her leadership.
This episode [from last year] covers the medical background of Dr. Patrizia Cavazzoni at the FDA. Her background is psychiatry and mood disorders, yet she is the FDAs Deputy Director for Operations at FDA’s Center for Drug Evaluation and Research (CDER).
Patricia Cavazzoni on Jeff Stephan show