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Msg  19595 of 19609  at  8/6/2022 6:09:22 PM  by

SuperM


AdCom

The Advisory Committee is being used for cover by the FDA n nothing more. It is just to please the public, patients, and advocacy groups so that they can claim transparency. I doubt they even go through the public comments and briefing documents. Statements such as Dr. Thambisetty stating that the 6-week timeline graph was very misleading to suggest that this company was trying to sneak one by the FDA. That's why in their presentation along with briefing documents they had the 12-week graph. Again it has been stated here before and I'll repeat it, that was a trial, Acadia was the defendant n Dr. Thambisetty was the prosecutor. He desperately wanted to control the narrative n influence the vote.
 
All that being said, had Pima gotten 3 or more yes votes then it's approved. Just look at what they continue to put the ALS community through with Amylx's AMX0035. A decision date on June 29th was delayed by 3 months following Canada's approval n a 4-6 Adcom vote. I'm guessing the FDA was going to deny approval on the 29th but being that Canada gave them approval 2 weeks before they decided on a delay so that according to them look over more analysis. 
 
The FDA has been playing both the ALS n Alzheimer's communities over n over with bureaucratic nonsense. In April of last year, they didn't care for discussions with Amylx. They told them to go do their phase 3 placebo-controlled trial and then get back to them. Following the backlash surrounding the Aduhelm approval, they then called them back to the table. IT IS ALL NONSENSE N ERRATIC! for anyone paying attention. Alzheimer's n ALS patients deserve better but everyone is getting played. 
 
A 3-month delay for approval.  The FDA figure we got a 4-6, with a little more convincing, we can get 2 more votes n give the community approval. It is all a show n nothing more! Three experts quit the AdCom last year because they have integrity and are too intelligent to realize when they were being used as tools.
 
Science? This is not about science or what is best for patients. It is a politicized bureaucratic mess filled with low-level employees who do the dirty work n a few lords within each division who ultimately decide on the science. 
 
 


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