RE:A shift to FDA’s decision making process? Well as per Abraham this is good news for biotech sector as FDA seems to be more flexible, more positive regulatory tone going forward.
From Barron’s report:
“FDA’s upcoming decision on aducanumab is not only binary for BIIB but also likely to reverberate throughout the biopharma sector, influencing overall sentiment on the space, perceptions on regulatory flexibility, and business development dynamics,” Abrahams wrote. “With sector sentiment negative, the adu decision has potential to rapidly turn perceptions around or, conversely, to double down on recent apathy.”
Another wild card, Abrahams writes, is that the decision could be taken by investors as an indication of the FDA’s mood. “We believe a common convergent view for some time has been that the FDA’s ruling on adu …would set the regulatory tone for years to come, particularly with a new administration,” Abrahams writes.
https://www.cnbc.com/2021/06/07/fda-approves-biogens-alzheimers-drug-the-first-new-therapy-for-the-disease-in-nearly-two-decades.html?__source=iosappshare%7Ccom.apple.UIKit.activity.Mail