Latest News - ADU won't be approved

ADCOM will vote NO. FDA will vote NO and will require additional phase 3 trial showing favorable results. One subset analysis will not cut it.

 

We all know this. Many analysts have relationships with physicians on the advisory committee and they clearly have voiced no.

 

When in history have you ever seen a drug get approved without two positive phase 3 trials completed? One reconfigured subset analysis with subpar data is not enough. No matter how much the medical community wants an AZ drug, is absolutely no reason to approve.

 

Agreed. You have to look at this from a science perspective and the data just isn't there yet.

 

Most that took jobs in this division were 2nd or 3rd options running from something. This gave them time to re-establish themselves knowing the likelihood this drug gets approved was very, very slim

 

The advisory panel will say no go. I have now heard this from 4 different financial analysts that scrutinize those on the panel. This is a cat and mouse game pharmaceutical companies do to leverage time. COnsider this as good work experience for another opportunity

 

You will be able to review public comments here. Note all physicians on the panel will be via phone due to chaos of COVID. The majority plan to cast no. FDA will agree to panel recommendations. Planned TBM Second wave hires will freeze. What they do with hired employees during this second immediate attempt is anyone's guess.

Peripheral and Central Nervous System Drugs Advisory Committee Meeting

 

ummm yeah, thats a no

 

The likelihood of approval is very poor. Many took positions here for the experience and to get through the terrible 2020. New job opportunities will come through in early 2021. Biogen will retain certain positions and eliminate others. This whole prelaunch in the industry is a joke but companies do this for a reason as it keeps them current and elevates stock price. No doubt it will be denied this round but they needed to test the market. They are gathering field intel they will need for the next feasible run and for other compounds in the pipeline. This is the priority now, not the approval.

 

Any chance some reps could shift over to MS and Tecfidera?

 

No. With generics out for Tec. there now be layoffs in the MS division. Stay tuned.

 

I know a top Neurologist involved in the clinical trials. They feel there isn't enough meat in the product to get approval for now. He stated this is creating an easier path for other treatments in knowing all the steps required for approval. Unfortunately, many just don't see this happening but at the same time if the clinical benefit is weak then it is understandable why the FDA would demand to see more data.

 

We all knew this was a distinct possibility for the last 6-9 months. Those that took the job in that division knew the risk, and they will be gone soon.

 

All the arrogance and elitism portrayed by the hiring managers and Sr Leadership will soon be rewarded with walking papers. KARMA always wins

 

Spot on. Biogen has 4 other ALzheimer’s drugs in pipeline. One of those is in Phase 3. So gathering intel is what this is all about.

 

15k applicants applied. And only the ones running from something got the gig right? Don’t be mad because you didn’t make the cut.

 

Not mad at all. Am laughing immensely.

 

The number of qualified applicants was much much lower. I have 10 years experience in neuro and after seeing the data that was available I was smart enough to realize it wasn’t getting approved. I called the hiring manager and bowed out. They people that were hired were most likely running from something so yes I would agree with that assessment

 

you talking about BAN2401??? Please it failed it’s last trial so it won’t get approved either. The other 3 Alz drugs are Phase 1. Your are done!

 

Thats why some positions will stay and continue on as there are other compounds in the mix. I'm not sure why Biogen is still strongly convinced there will be an approval. I think they just want to convince people they think that. It's not enough data and entirely too soon, but the company is benefiting from all the hype about it.