Alzheimer comme je l ai posté phase 3 pour 2023

https://www.biopharmadive.com/news/fda-approval-decisions-first-quarter-2021/592822/?utm_source=Sailthru&utm_medium=email&utm_campaign=Issue:%202021-01-05%20BioPharma%20Dive%20%5Bissue:31713%5D&utm_term=BioPharma%20Dive

Biogen's aducanumab for Alzheimer's

The FDA is facing a no-win decision on Biogen's Alzheimer's treatment aducanumab. After collaborating with the company on review of its approval application in spite of mixed and controversial data, a panel of outside advisers voted decisively against the drug's benefit-risk profile.

Now, if FDA follows the advisory committee's advice, it risks disappointing the patients, families and advocates who have pushed for new Alzheimer's therapies. If regulators ignore the committee, they risk damaging their reputation as independent arbiters of safety and effectiveness.

How the agency chooses will have enormous consequences, not least of which will be the ripple effects on Alzheimer's research. Many drugs that work similarly to aducnaumab, which blocks the accumulation of a protein called amyloid beta in the brains of Alzheimer's patients, have failed previously.

While most Wall Street analysts doubt the FDA will approve the drug, some are holding out the possibility of a surprise by the decision deadline of March 7.

"There are two reasons that FDA could go against the recommendation," Stifel analyst Paul Matteis wrote in a Dec. 17 note to clients. "[First], FDA briefing documents were overwhelmingly positive, and [second] one thing that's clear is FDA believes aducanumab is safe, even in the community setting

une phase 2b/3 n est pas une phase 3 réponse du PDG de ab science...

https://www.bioworld.com/articles/501460-ab-science-shares-rise-on-preliminary-masitinib-data-in-alzheimers