FDA advisers reassert case against approval of Biogen's Alzheimer's drug | BioPharma Dive

https://www.biopharmadive.com/news/aducanumab-fda-advisers-jama-alzheimers/597643/

 

Poof.

 

Biogeny said today that Alzheimer's drug is finished and not going to happen

 

Biogen should have stayed as far as possible from Eisai, the Typhoid Mary of the pharmaceutical industry.

 

You still have no proof. Put up or shut up.

 

Are you joking? Read what the FDA has said about the drug. It's a dog. You must be high or, maybe you can't read.

 

This comment says it all. You're a legitimate moron. FDA hasn't said anything negative about the drug. In fact, the briefing document from the FDA prior to the adcom in November offered a VERY positive and encouraging view of adu. It was the advisory board, who are NOT FDA and are NOT deciders, that held the negative view. This is exactly why you reps are kept at an arms length. You're glib, arrogant, and dumb as hell.

 

Are you for real! The FDA has followed the advisory board views 98% of the time. Why, because the advisory board is made up of doctors that treat the indication, the FDA panel are doctors that could be ortho or Pediatric or oncologist that do not treat alzheimers. Learn about how it works then speak up. 1 doctor had positive things to say and, it was found out the doctor is in bed with Biogen. Go read the full article and others that have been written.

 

There’s also another important item you forgot to mention. The FDA is responsible for seating the advisory committee members, so they’ve basically vetted their recognized scientific and technical expertise. It’s a little hard to completely discount and disregard their opinion once you’ve done that. The committee members aren’t just some random clinicians out there in the field who might have an axe to grind or be malcontents.

 

Alex did the dude.

 

You are correct and, that's why they follow the advisory panels advise. I hate to see this not get approved for patients and Eisai but, I'm not sure it's going to or should happen.