Amylyx

Quote


















Not to get political or anything but I think under Trumps administration, this would've had a decent shot of getting approved. With the new FDA commissioner appointed by Biden, I think the chances are now very slim. Given the Adulhelm fiasco and MT's disaster that doesn't work, Amylyx will have to prove that this drug works with P3 study. Also hurts that the CEOs of this company are young and have no ties/relationships/lobbyists with FDA. Best of luck to everyone but this has maybe a 10% chance of approval.
 






anonymous said:
Not to get political or anything but I think under Trumps administration, this would've had a decent shot of getting approved. With the new FDA commissioner appointed by Biden, I think the chances are now very slim. Given the Adulhelm fiasco and MT's disaster that doesn't work, Amylyx will have to prove that this drug works with P3 study. Also hurts that the CEOs of this company are young and have no ties/relationships/lobbyists with FDA. Best of luck to everyone but this has maybe a 10% chance of approval.
Click to expand...

the CFO’s brother is the late Pete Frates brother. google that. lots of connections. research more.
 


















anonymous said:
it’s call politics, we will see this approved.
Click to expand...

i have zero skin in this game. I just recently left Biogen. Just thought I would say that predicting is near impossible in this situation. People want to compare it to Aduhelm or other scenarios, but there are plenty of different factors. You have no adcom members going bonkers in the press adamantly opposing it. There is no accusation of being in bed with the FDA. The drug is perceived as pretty safe. The adcom vote wasn’t that bad - an adcom member actually took your side of statistics! Yes, the FDA was more critical, but that could be an act after Aduhelm. The data really isn’t much, but for a disease like this with so much advocacy and political power AND the fact that it’s safe and not perceived as bankrupting Medicare, I think there’s a strong chance of full approval. I do not think accelerated approval is an option. Your own co-CEO said that there is no surrogate endpoint. Even if there were, the FDA justified adu’s with data from 3 other drugs that showed correlation between the biomarker and clinical benefit, You can’t have AA w/o a surrogate endpoint likely to predict clinical outcome.
So, hang in there and good luck! Thankfully there are a lot of jobs out there right now and I have been shocked at how competitive the salaries have been. If it doesn’t get approved, you will land on your feet soon enough.
 






anonymous said:
i have zero skin in this game. I just recently left Biogen. Just thought I would say that predicting is near impossible in this situation. People want to compare it to Aduhelm or other scenarios, but there are plenty of different factors. You have no adcom members going bonkers in the press adamantly opposing it. There is no accusation of being in bed with the FDA. The drug is perceived as pretty safe. The adcom vote wasn’t that bad - an adcom member actually took your side of statistics! Yes, the FDA was more critical, but that could be an act after Aduhelm. The data really isn’t much, but for a disease like this with so much advocacy and political power AND the fact that it’s safe and not perceived as bankrupting Medicare, I think there’s a strong chance of full approval. I do not think accelerated approval is an option. Your own co-CEO said that there is no surrogate endpoint. Even if there were, the FDA justified adu’s with data from 3 other drugs that showed correlation between the biomarker and clinical benefit, You can’t have AA w/o a surrogate endpoint likely to predict clinical outcome.
So, hang in there and good luck! Thankfully there are a lot of jobs out there right now and I have been shocked at how competitive the salaries have been. If it doesn’t get approved, you will land on your feet soon enough.
Click to expand...

sorry to hear that about Biogen
 






anonymous said:
i have zero skin in this game. I just recently left Biogen. Just thought I would say that predicting is near impossible in this situation. People want to compare it to Aduhelm or other scenarios, but there are plenty of different factors. You have no adcom members going bonkers in the press adamantly opposing it. There is no accusation of being in bed with the FDA. The drug is perceived as pretty safe. The adcom vote wasn’t that bad - an adcom member actually took your side of statistics! Yes, the FDA was more critical, but that could be an act after Aduhelm. The data really isn’t much, but for a disease like this with so much advocacy and political power AND the fact that it’s safe and not perceived as bankrupting Medicare, I think there’s a strong chance of full approval. I do not think accelerated approval is an option. Your own co-CEO said that there is no surrogate endpoint. Even if there were, the FDA justified adu’s with data from 3 other drugs that showed correlation between the biomarker and clinical benefit, You can’t have AA w/o a surrogate endpoint likely to predict clinical outcome.
So, hang in there and good luck! Thankfully there are a lot of jobs out there right now and I have been shocked at how competitive the salaries have been. If it doesn’t get approved, you will land on your feet soon enough.
Click to expand...

FDA should not approve this therapy until the new study is complete and results in. In the meantime the company can still give it away under the EAP. How does that work for the Co-CEO bros?
 












anonymous said:
i have zero skin in this game. I just recently left Biogen. Just thought I would say that predicting is near impossible in this situation. People want to compare it to Aduhelm or other scenarios, but there are plenty of different factors. You have no adcom members going bonkers in the press adamantly opposing it. There is no accusation of being in bed with the FDA. The drug is perceived as pretty safe. The adcom vote wasn’t that bad - an adcom member actually took your side of statistics! Yes, the FDA was more critical, but that could be an act after Aduhelm. The data really isn’t much, but for a disease like this with so much advocacy and political power AND the fact that it’s safe and not perceived as bankrupting Medicare, I think there’s a strong chance of full approval. I do not think accelerated approval is an option. Your own co-CEO said that there is no surrogate endpoint. Even if there were, the FDA justified adu’s with data from 3 other drugs that showed correlation between the biomarker and clinical benefit, You can’t have AA w/o a surrogate endpoint likely to predict clinical outcome.
So, hang in there and good luck! Thankfully there are a lot of jobs out there right now and I have been shocked at how competitive the salaries have been. If it doesn’t get approved, you will land on your feet soon enough.
Click to expand...

anyone with ALS is going to end up medi/medi.
 






























opening in NYC
what kind of base range we looking at? hows the management?
NYC is a beast accesswise... wondering if its worth even looking into.
over a decade neuro and launch experience, none in neuromuscular however.
 
























Top Bottom
Back
Quote