The FDA wants to approve aducanumab for Alzheimer's disease, but is trying to find away around its a

[anonymous]

https://seekingalpha.com/article/4408165-biogen-and-politics-of-alzheimers-disease

'But the problem is that it has not worked. The FDA, Biogen, and the Alzheimer’s Association all can reap benefits from an approval, but they also face major credibility problems if aducanumab turns out to be another Sarepta. Rightly or wrongly, Biogen’s stock value has been buoyed when results for aducanumab have looked good (nearly 480 points) and sunk when the drug appeared to fail (just below 220 points). The FDA’s decision will likely push the company’s stock value up or down into one of these orbits again."

• Investors should not bet on FDA approval, but instead reduce some of their exposure in case the agency does not.

 

[anonymous]

https://seekingalpha.com/article/4408165-biogen-and-politics-of-alzheimers-disease

'But the problem is that it has not worked. The FDA, Biogen, and the Alzheimer’s Association all can reap benefits from an approval, but they also face major credibility problems if aducanumab turns out to be another Sarepta. Rightly or wrongly, Biogen’s stock value has been buoyed when results for aducanumab have looked good (nearly 480 points) and sunk when the drug appeared to fail (just below 220 points). The FDA’s decision will likely push the company’s stock value up or down into one of these orbits again."

• Investors should not bet on FDA approval, but instead reduce some of their exposure in case the agency does not.

Sounds like the FDA wants to say yes, but unlike Sarepta where it was a split vote, they have a unanimous vote NO against ADU to contend with. FDA will lose a great deal of credibility if they say yes to a therapy with little proof of efficacy. What does this also say to the ADHOC? The real question is who will pay $$$$$$$ for all this? There is no doubt there are better drugs in development just behind ADU.

Being in the SMD group at Biogen, we discuss this all the time. If it were to pass, the indication would be so tapered down and the REMs so extreme, that the job would be one of the most painful in the industry and the ADU employees will be 24hr/7d punching bags. No thank you for all the tea in China.

 

[anonymous]

FDA will approve. They have no choice

 

[anonymous]

The FDA doesn't have to do sh!t. Lilly and a few other companies have the answer.. with two studies each. Biogen was a gem years ago, now its Novartis flunkies doing what they do... nothing.

 

[anonymous]

FDA's Woodcock loves Biogen and will do anything for them lol

 

[anonymous]

We are saved by frat boy with the flop and Pat (deb) as our leaders, Their joint venture will ensure we rise to the top.
Signed,
His/her

 

[anonymous]

That is a good one. They are in over their heads for sure. Didn’t someone ask them about how to handle a crisis?

 

[anonymous]

There’s plenty to criticize Deb about. No need to be ignorant and transphobic.

Start with cramming all the adu reps in and moving the goal line 100 tines.

We are saved by frat boy with the flop and Pat (deb) as our leaders, Their joint venture will ensure we rise to the top.
Signed,
His/her

 

[anonymous]

Deb is probably the only cool thing about the ADU franchise. She identifies as female now and I could care less if that was assigned birth or not. My opinion of ADU and the company has changed however after really looking at the data and their response to it. The advisory groups like AA seem corrupt just like those in the medical community that are pushing so hard simply because it pushes their agendas as businesses $$$ and increases their validation. this has nothing to do with patients. There are better drugs in the pipeline now. The FDA should so the right thing and request a second study. No one wants to do that because it is a very good chance the data cannot be replicated.

 

[anonymous]

I believe that was the OP point. Has nothing to do with Deb the person.

This is about ability and vision...

And the short-schrift on adu data to FDA is almost immaterial at this point. The point is Biogen increased the size of the company by almost a 9th in a year. There are consequences for that.

Deb is probably the only cool thing about the ADU franchise. She identifies as female now and I could care less if that was assigned birth or not. My opinion of ADU and the company has changed however after really looking at the data and their response to it. The advisory groups like AA seem corrupt just like those in the medical community that are pushing so hard simply because it pushes their agendas as businesses $$$ and increases their validation. this has nothing to do with patients. There are better drugs in the pipeline now. The FDA should so the right thing and request a second study. No one wants to do that because it is a very good chance the data cannot be replicated.