Amylyx



































































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

We listened to the call today and Henri Termeer is rolling in his grave. This company was built on making fast money through being sold to another company with bullshit science. Leadership you all should be ashamed of yourselves.
 






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.”
 












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.”

Patients who have ALS need a real solution and applaud the FDA for not letting a greedy company exploit them and the public.