The Endpoints News poll: Should the FDA panel back an approval for aducanumab, or should they send Biogen packing?
There’s been a considerable amount of back-and-forth over the relative merits, or lack thereof, in Biogen’s application to market the Alzheimer’s drug aducanumab.
Biogen execs have been absolutely steadfast — at least after their second take of the data — that they’ve proven that a consistent high dose of their drug can moderate disease progression. Critics say it’s a post hoc mess filled with bias and blown so far off track that Biogen can’t come close to meeting the agency’s requirement of positive data from 2 well designed studies.
Biogen says it will take 5 years to run a new study and patients deserve something now. At least one expert says that a new trial can be done in much less time.
Biogen has the market cap riding on this one, and won’t go quietly in the event of a CRL.
On Friday an expert panel will offer their opinion. But we’re running our own survey in advance.
If you’ve been following this story, you likely have an opinion on whether the FDA expert panel should, or should not, vote to back an approval. And we’ve served up 2 key questions — Will they do it? Should they do it? — for you to take a crack at. And there’s a place to offer your opinion on both, should you choose to do so.
You can take the poll here.