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Saturday, June 12, 2021 11:03:41 AM
I think it is notable that three professionals stepped down from the AdCom in this particular case and that is my interest. In further reading, I found this article to be more specific in defining the difference between the AdCom and the Agency conclusions:
“The 11-member committee voted nearly unanimously in November that Biogen's drug should not be approved, citing inconclusive evidence that the drug was effective.
The FDA on Monday gave the drug "accelerated approval,” based on evidence that it can reduce a likely contributor to Alzheimer’s, rather than proof of a clear benefit against the disease.”
https://www.nbcnews.com/news/us-news/third-member-fda-advisory-panel-resigns-over-alzheimer-s-drug-n1270428
The decision seems odd to me; however, the story here is intriguing and I have no idea how these decisions might affect NWBO.
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