ADU Layoffs

When is it going to happen. This is ridiculous. Give a holiday package and send on our way.

 

You won’t get a damn thing cuz you could never sniff a job at a company like this.
#basementboytroll

 

Probably no lay-off s till March when official rejection comes from the FDA,
Continue to do nothing till then an
save your money.

 

This is absolutely crazy. I’ve been sitting around doing nothing. My territory is closed if we actually did have a drug to sell.

 

Expect layoffs in January as more studies will be requested at that time.

 

And you are getting paid which is a good thing It's the pharma version of unemployment! There are a lot of unemployed folks on the street right now so be thankful you have a paying job.

 

Nothing will happen with FDA until next year. The data set is very convoluted and the advisory committee was basically demanding an additional study. This makes a lot of sense given this will affect such a large human population and results need to prove replication and not chance. The FDA really should follow suit with the Advisory Committee, especially since it was a very definitive no. Basically a land side no. Biogen should do the right thing and spend the money for an additional study.

 

Unfortunately the enrollment wasn't identical but you can simply go by hypothesis on why the second study did not show efficacy. You can't do that. You have to prove that!

 

Agreed! It is a crazy story to try and tell and it will give physicians a headache. Clearly another study is needed!

 

When I spoke to an Account Liaison manager she said approval was expected in Nov? I know I saw March as pdufa date. But why was she under the impression approval was earlier then March? I did not pursue the role. I wasn’t confident in the drug or Biogen. I have worked for Biogen before...

 

She only said that as she is trying to excite/sell you as a candidate as much as you are trying to get the role. Obviously after Advisory, you were wise to pass

 

Are they really moving forward for January hires after the poor review last week? They’re grasping at straws

 

January rather than March?

 

This was all handled poorly from the beginning. FDA's biased Billy Dunn showed his cards way too quickly and spoke to the press on how excited they were about Aducanumab and the data was outstanding. Many have called him out, stating he plans to leave the FDA and go into industry. He has worked very closely with Biogen.. The FDA's premature comments caused the stock to soar as it was all over the press. When the ADHOC meeting met however, almost unanimously the expert panelists voted no. They voted no for very good reasons. The data is very week and Biogen wants everyone to dismiss the results of the second phase 3 trial while looking at just one study. Even the favorable study is not strong.
Many would argue that because the FDA came to Biogen and they praised the drug prior to the approval, that they will get approval. Biogen is continuously in communication with the FDA. You have organizations wanted the drug approved because in their minds it will cause exiting patients to go without hope for additional years.
The ADHOC committee did, however, get it right. Another phase 3 trial needs to be developed and the FDA should go with the ADHOC's recommendation.
The FDA needs to do the right thing and request an additional study. With a vehement no from the panel, the FDA needs to realize more is needed before coming close to any kind of approval.

 

Product will receive approval in March 2021. Rejected candidates gonna hate!

 

No way it gets approved in March

 

Agreed. The trial design "story" is complicated and a bit of a mess. Just do the right thing and extend the time to do a proper second trial.

 

Lemere has worked on medical educational material about Alzheimer’s for Biogen, and serves on the medical and scientific advisory group of the Alzheimer’s Association. The association submitted a statement to the panel supporting approval of aducanumab, highlighting the ‘drastic need to offer relief and support to the millions of Americans impacted each day by the crushing realities of Alzheimer’s.’ Lemere predicts that the FDA will likely ask for additional phase 3 studies, which could take four to five years. ‘It is rare that the FDA would go completely against the panel,’ she says, although they could opt for conditional approval, requiring Biogen to monitor patients and produce more data for later review.

John Hardy at University College London, UK, says many fellow Alzheimer’s scientists he is in touch with are struggling to decide whether approval is justified for aducanumab with the data to hand. He sympathises with FDA’s predicament. Nonetheless, such post hoc analyses ‘even if plausible, are dangerous,’ he adds.

‘One thing we can say for certain,’ says Hardy, ‘is that this is not a drug which has a major effect on the clinical progression of the disease.’ Any effect it does have is likely to be relatively small. Nonetheless, with no other effective treatments for Alzheimer’s, the FDA will be under pressure to approve aducanumab. Hardy points to the drug tacrine (Cognex) as an example of an Alzheimer’s drug that was approved under pressure on the basis of poor trial data and withdrawn in 2013.

Aisen says the interim analysis has done a huge disservice to everyone. ‘We set up our trials to give us an answer at the end of the trial; and then we try to make a decision in the middle,’ he says. Such futility analyses are intended both to save companies money and reduce risks to volunteers if trials are obviously hopeless, but by definition lack the statistical power to judge small effects. ‘We should be much more cautious in interpreting [futility analyses], because they are based on incomplete datasets,’ Aisen says.

 

Are you on the crack pipe?