Watching an FDA advisory committee tear apart the data his former competitor submitted seeking approval of its potential drug for Duchenne muscular dystrophy, Chris Garabedian felt some amount of vindication.
The former CEO of Sarepta Therapeutics (Nasdaq: SRPT), who stepped down in March as the company faced mounting hurdles, watched via webcast as the federal agency debunked several claims made by BioMarin Pharmaceuticals (Nasdaq: BMRN) to explain deficiencies in the trial data for its drug, drisapersen. Many of those claims were based on so-called post hoc analyses — finding patterns in the data after a trial has been completed in hopes of explaining why the data didn’t end up supporting the original hypothesis.
