Adam F. The Street copy and paste quote into google for reference
The convincing efficacy and safety data generated already, coupled with powerful patient testimony, would make it extremely difficult for any expert sitting on the panel to vote against eteplirsen.
I say, bring on FDA panel. It's a positive for Sarepta.
Sentiment: Strong Bu
Here’s my take. SRPT is down 5.78% today based largely on unsubstantiated comments by some, extrapolating FDA regulatory reluctance to approve SRPT’s Duchenne muscular dystrophy drug, eteplirsen, because the drug has been tested on only a handful of patients, from the 85% fall yesterday after announcing recalling Affymax’s Omontys, a treatment for patients on dialysis with chronic kidney disease, because of potentially fatal allergic reactions in some patients.
The FDA expedited approval process for rare diseases was created expressly because trial’s on a large number of patients is not possible, when the affected population is small. The FDA commissioner recently was interviewed on this phenomenon and responded that by its nature failure rates will be higher. Eteplirsen, clinical results will likely be reviewed on it’s merits and not a revamped and stricter regime prompted by Omontys unfortunate failure.
This premature conclusion by bloggers without standing, may be a case of “ those who know don’t talk, and those who talk don’t know”.