The FDA just signed off on a Formula 1 pivotal track for Sage's postpartum depression drug
Sage Therapeutics says the FDA has signed off on an astonishingly short clinical development pathway for postpartum depression which may allow for an approval after a pair of tiny Phase II studies which are already underway.
These two mid-stage studies — 202B and 202C — will read out in the second half of next year. And Cambridge, MA-based Sage says that the minutes of its FDA meeting make clear that the biotech only needs to make a few small adjustments, including an increase in sample size, to make these studies registrational.
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