Biotech Stocks and Advisory Committees: No News Is Good News?
This article was originally published in RPM Report
FDA has approved six new molecules already in 2012--and five were approved without going to an advisory committee. Meanwhile, FDA has held four advisory committees to review new drug applications, and all four ended in overwhelming "no" votes.
You may also be interested in...
Despite a “yes” vote from an advisory committee, FDA sent Chelsea’s Northera back to the development phase with a complete response letter asking for data from another trial. There may have been nothing Chelsea could have done to get a better result—but the company could have held off on a post-panel victory lap.
Shire’s decision to take its Fabry Disease therapy and go home sets up two possible narratives. One accentuates FDA’s apparent inflexibility and is sure to reinforce calls for legislative changes to the approval standard. The other highlights a recalcitrant or even petulant-sounding sponsor. Neither is likely to sound good to Fabry’s patients.
A key date was removed from FDA’s tentative advisory committee calendar. But a panel is still expected to review BMS’s anti-clotting agent Eliquis and a new indication for J&J’s Xarelto in ACS.