miércoles, 4 de diciembre de 2019

Pick a side in the Biogen debate

The Readout
Damian Garde

Pick a side in the Biogen debate

On the subject of Biogen and its much-discussed treatment for Alzheimer’s disease, SVB Leerink analyst Geoffrey Porges contends that “the probability of [FDA] approval is high.” Baird’s Brian Skorney, by contrast, says Biogen’s drug “is not getting approved absent a deus ex machina.”

And the consensus, to the extent there is one, is somewhere in between, judging by Biogen’s stock price. That could change on Thursday, when the company will present detailed data on aducanumab, its once-waylaid Alzheimer’s drug. As STAT's Rebecca Robbins reports, experts will be looking for evidence that Biogen’s declaration of clinical victory is more than a matter of chance and small populations. She has four key questions.

Meanwhile, Biogen’s confidence hasn’t wavered. “Here’s the decision that FDA is going to have to make,” Chief Medical Officer Dr. Al Sandrock said at last month’s STAT Summit. “Do we believe there is enough evidence to approve it now? Or do we ask the company to do another trial, wait five years, and how many people have to get demented in that time period?”

You can watch a video of the full session with Sandrock here.

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