Haaafuckinghaaaa!! FDA has second thoughts, more to come.
exactly why I was not interested in this job- not gonna happen this yearHaaafuckinghaaaa!! FDA has second thoughts, more to come.
exactly why I was not interested in this job- not gonna happen this year
the is no chance this doesn’t get approved. You’re a fool to think otherwise and extremely ignorant to the community this diseases impacts.
Don’t forget that the FDA is still kicking it’s self after approving Aduhelm and don’t think they will make the same mistake again.
Don’t forget that the FDA is still kicking it’s self after approving Aduhelm and don’t think they will make the same mistake again.
Don’t forget that the FDA is still kicking it’s self after approving Aduhelm and don’t think they will make the same mistake again.
Don’t forget that the FDA is still kicking it’s self after approving Aduhelm and don’t think they will make the same mistake again.
The FDA has a meeting with them today 10-5. Link available
the is no chance this doesn’t get approved. You’re a fool to think otherwise and extremely ignorant to the community this diseases impacts.
it is possible it gets approved but this will be another controversy. but seriously at some point the science and integrity of the trial design needs to be considered. Otherwise why do we have a rigorous approval process ??
if it doesn’t get approved it’s because the science and evidence does not warrant it, and will also be because leader ship at this organization ignored FDA guidance on trial design.
good luck
it is possible it gets approved but this will be another controversy. but seriously at some point the science and integrity of the trial design needs to be considered. Otherwise why do we have a rigorous approval process ??
if it doesn’t get approved it’s because the science and evidence does not warrant it, and will also be because leader ship at this organization ignored FDA guidance on trial design.
good luck
Amylyx leadership should be ashamed of themselves for sure.
A quote from the news today regarding the FDA review:
“A panel of scientific advisors to the Food and Drug Administration on Wednesday narrowly opposed approval of a new drug designed to treat amyotrophic lateral sclerosis, or ALS, concluding that data from the sole trial of the drug did not prove that it was an effective treatment.
The members of the advisory voted 6 to 4 against the notion that the drug developed by Amylyx Pharmaceuticals' (ticker: AMLX), AMX0035, had been shown to be effective against ALS.”
the is no chance this doesn’t get approved. You’re a fool to think otherwise and extremely ignorant to the community this diseases impacts.
Hey ass clown, who is the fool now?
What morons left awesome jobs 2 weeks ago to go to this stupid farce of an organization. Lack of judgment can you say?
No final decision was made that was just the advisory committee. Remember they said no to Biogen at their advisory committee and went on to approve it. People are dying from this devastating disease. You should be so arrogant.