Biogen Alzheimer's Expansion

All signs are pointing towards a delay as the FDA will want more data.

 

What signs are those?

 

Agreed. The FDA will issue a CRL.

 

FDA experts on here. Very impressive. Next time they call you and give an update, share it. Thanks!

 

Your mom wants more data.

 

Joe Biden here so listen up. Let's get this drug out before my debate with Reagan. chop, chop

 

Do you know anything? They did not have to use their voucher. Do you understand how a rolling submission works? Thank goodness you geniuses didn’t get hired.

 

Anyone getting these ridiculous calls from a Princeton One every 3 weeks? Just want to make sure you’re still interested, the hiring mgr is getting closer...been going on for months

 

Its all a game. All recruiters are whores to the process and are simply paid to keep you on the hook. I know, because I am one and we have our "retention candidate pool", just like the attainment quota you all hang on to as drug reps! If you haven't had a face to face with a Regional Manager at this point, move on!!!
You are simply our "little bitches" to the system at this point and shame on you if you feel you you are still in the mix. These jobs have been filled for weeks. Many of you have been out of work for months and its time to move on and find another career.

 

Never getting approved.

 

Time to clear up some things around this priority review designation. Yes, they did not use a Voucher, but this designation also came with the FDA stating they will hold an Advisory Committee Review & hearing. This is NOT the norm with drugs granted priority review. If the data was a slam dunk and that is why the priority review was granted, there wouldn’t be an advisory committee.

This points to the FDA likely granting this out of some form of internal and external pressure with the optics of what would look like delaying Alzheimer’s treatments around bureaucratic red tape. Here they get to act quickly, and have the advisory committee pick this apart for the incomplete study and submission. My bet is a CRL and they need to do another Phase 3 tailored and designed to answer if this actually works

 

Bingo. They will NEVER EVER approve a drug with two failed pivotals. The only positive signal was in a non predefined subset of patients. A repeat phase 3 will be the outcome, at best.

 

Many drugs are approved with 2 failed studies. Especially in subjective therapies like depression, etc

 

As someone with internal knowledge, this is closest to accurate. Another pivotal trial will be necessary, and most of those currently in the space will have to be reassigned (highly unlikely) or let go. We have downsized multiple times in the past, and that is the formula that will be used. 90% likelihood at this point.

 

There’s a reason why there has been a recent mini-wave of departures from R&D Director to VP level in the last several weeks to 2 months.

 

Ooooohhhhh...I’m so scared!! If it doesn’t get approved, I might have to *gasp* go find a job, just like I did when I came here. If it is approved, I’ll be part of something amazing that changes the face of a devastating disease forever.

I’m not worried in any way, as I’m already here and approval isn’t my decision. And, if the outcome isn’t good (which is actually incredibly unlikely), I’ll just go get a new job, just like thousands of pharma folks do every year. Big fucking deal.

 

I am not interested in the job, just checking here for a friend that looks like she is being strung along by a recruiter. I recruited for a number of years, and yes, they are keeping y’all on the hook just in case the drug does get approved. Recruiting is a nasty business. You have to send people on interviews that have no chance because the company has to have a certain number interviewed. Looks like this drug is in for a CRL and/or another Phase 3 study. Thanks for the info.

 

I am not interested in the job, just checking here for a friend that looks like she is being strung along by a recruiter. Quote

This is absolutely hilarious. Gezzzzz where do they find these clowns.

 

....says the low-level-literate-dumb-ass that typed "Gezzzzz"

 

But really “I’m just posting for a friend” come on man your post was lamest post ever! C ya pea brain.