Latest News - ADU won't be approved

let me spell it out for you. over 30% of the patients in the trial experienced brain swelling at the higher dose and the higher dose is the only dose that showed real result, bottom line that ris is too high for approval without more studies it’s OVER!!

 

I’m on the MS side and a huge believer in Capitalism and the US Healthcare System. I am confused as to how an ineffective, expensive medicine would HELP the patients and DECREASE the $1 trillion dollar cost - it would only add a false hope, increase secondary problems, and increase the cost.

 

let me spell it out for you. over 30% of the patients in the trial experienced brain swelling at the higher dose and the higher dose is the only dose that showed real result, bottom line that ris is too high for approval without more studies it’s OVER!!

 

THIS!!! For once someone makes sense here. Get over it dummies! You’re all screwed.

 

FUCK OFF!!!

 

I don't think they will have enough yes votes from the committee. The safety is a real concern. Is it me or doesn't it look odd that the company saw no clinical benefit "then went back and relooked at the data" ????

 

Biogen's reprieve as critic recused from aducanumab panel, but analysts still read rejection in the tea leaves

 

Analysis calls for further late-stage study of Biogen, Eisai's aducanumab

 

Oh my!
FDA bars critic from review panel of Biogen's controversial Alzheimer's drug

 

Actually meaningful benefit is very difficult to show in AD drugs. It was the same for Aricept & Namenda

 

I think they need 7 yes votes.

 

I think the drug gets approved but with a label so restrictive that selling it will be extremely difficult, probably come with a significant REMS as well?

 

https://www.cnbc.com/2020/11/04/biogens-stock-jumps-30percent-after-fda-staff-says-it-has-enough-data-to-support-approving-alzheimers-drug-.html

 

Biogen always crafty about finding a way to message weak data to make an argument that the drug actually delivers a significant benefit. No way this drug deserves approval. Yet no doubt the price will be hefty. Manipulation of the stats, i.e. "cherry picking" like the pivotal trial that got approval for Avonex to treat RRMS. WEAK but kind of enticing when a treatment is sorely needed in a particular nasty disease state. Kind of a "Oh, why not give it a try?" conclusion. I guess investors really appreciate the extra effort to gain approval, despite the imminent disappointment of the family members of the patients who will drain their savings to get poor results? Keep up the good work-share price is up!$!

 

Stock up to 108 today , someone must think good news coming soon

 

Wow, crickets on the cafe pharma boards past day. Weird. Where the haters at?!?!!!

 

market manipulation,all companies do this with leaked out information. I have always said the drug would get approved but with what type of label? Remember Sage’s drug got approved and now they don’t exist?

 

Sell now - going back down Monday

 

Felt so bad for the people begging for hope and then having to listen to a bunch of experts on trial design, p values, and endpoints. I hope people will still get access to it through a compassionate care program if it’s not fda approved.

 

This drug is as polarizing as it gets. Thumbs up or thumbs down today doesn’t matter. The final word will be in March.