Anavex Life Sciences Corp (AVXL)

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"lowlife corrupt..."..absolutely correct...

Internal clashes caused last-minute chaos at the FDA
There were substantial internal disagreements over Aduhelm between two parts of the FDA: the Division of Biometrics, which does statistical reviews to ensure the safety and effectiveness of new drugs, and the Office of Neuroscience. The full extent of the dispute became apparent only about 10 days before an analysis for FDA advisers was due. FDA leadership scrambled, but ultimately weren’t able to fully resolve the disagreements before the presentation, and the analysis critical of Aduhelm was only included as the very last appendix in a more than 300-page report.

Collaboration between the FDA and Biogen was ‘atypical’
The FDA’s and Biogen’s joint preparation of a briefing document and a presentation for the FDA advisory committee meeting in November 2020 was unusual. It’s an approach that the FDA had previously used only nine times, investigators wrote, and never before in the neuroscience office. Generally, the agency’s and drug manufacturers’ analyses and briefing documents are separate and independent. By contrast, Biogen worked so closely with the FDA on the briefing document that it was difficult to distinguish between who wrote what, congressional investigators found.

https://www.statnews.com/2022/12/29/8-key-takeaways-from-investigation-of-alzheimers-drug-aduhelm-approval/