Biogen Alzheimer's Expansion

It’s only amazing for patients if it actually works.
Otherwise it’s an expensive, burdensome, safety hazard.

 

Hmmmm...pretty sure that’s what the FDA determines when deciding whether or not to approve it. Hence, I hope it gets approved; the assumption being I hope it also benefits patients.

No one hopes it gets approved and doesn’t work for patients. Sorry you needed that spelled out for you. I’m pretty sure no one here is in the business of wishing bad things on Alzheimer’s patients. We’ll leave that up to you.

 

I’m sure the fact that all the pivotal studies failed will impress them. You don’t get to make up the rules after the fact to show a benefit where none exists. Sorry you needed that spelled out for you.

 

You don’t work for the FDA and aren’t the one responsible for determining the quality of the clinical data or the potential impact on patients. We don’t care whether or not you like the data; we only care what the FDA thinks. Sorry you needed that spelled out for you.

 

Here’s what I I know...(have connection to FDA) is that drug will more than likely be approved after CRL and and delay...q2 2021.

 

That made sense up until you said it would be available Q2, 2021 - after a delay. That is the earliest it could be available without a delay - I’ve heard 2022 at the earliest

 

Good thing you have Tecfidera exclusivity and revenue to fall back on....

 

Here’s what you know....shit.

 

So I got a call from a recruiter about an opening in my are. I thought all these offers were already made??? WTH is going on with this hiring process? Hasn’t it been going on since before covid even hit?

 

I got P1 phone screen and asked her who the biggest competitors were and she rattled off 2 MS drugs Nuff said

 

A CRL in this case most likely would require a new Phase 3 study. You’re looking at 2.5-3 years absolute min before they have data for any sort of re-submission, then at least 4-6 months for FDA review, maybe a few months more. And good luck launching a new phase 3 in this environment where patients are not showing up to participate in trials and are skipping visits in large numbers

 

Never seen a recruiting process drag on for over 8 months now. Crazy

 

This person gets it. Only reason FDA agreed to review is they want to see the data so they can better advise other companies. You need two positive (usually phase 3) trials to get approval.

I would bet substantial money that a new phase 3 with proposed responding population will be required.

 

honest answers please.
I've been in the hiring mix for 8 months. Never knew about a wave 1 or 2. I went through interview process and was told by hiring manager that the dates were pushed back until Dec and wanted to know if they could circle back to me then. I called P1 at the time and they said the territory was filled but I was still in the loop for wave 2. Today they called and said I'm no longer being considered. Did they cancel the phase 2 wave. I was under the impression that my area never hired anyone for wave 1 since manager said dates were pushed back and made it seem as if it was on hold in the area. Just looking for an honest answer. Thank you!

 

This is exactly what happened to me. I got the call from P1 last week- not even the recruiter I’ve been speaking with. Said they went with another candidate! I’ve been strung along since February! I don’t know exactly what happened either. But I’m kind of glad it worked out the way it did.

 

Internally at Biogen they are giving up on this compound

 

Obviously a troll and obviously the same dumb ass posting they have an inside connection at the FDA.

 

It’s a bust.

 

Your situation is real. This damn process began all the way back in Feb 2020 before the pandemic. Never seen such a shit show recruiting process before. You have candidates that been strung along for 8 months waiting for answers just like you have brand new applicants waiting to hear about their very 1st interview. It’s a total cluster!

 

Feel free to pull yourself out of consideration for the openings. No one forced you to apply.