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