May 31, 2013, 1:47pm EDT
Sarepta’s meeting with FDA now expected later than first hoped
Sarepta President and CEO Chris Garabedian said the $125 million stock offering is the largest in the company's history.
Chris Garabedian, CEO, Sarepta Therapeutics
One day after the CEO of Sarepta Therapeutics Inc. (Nasdaq:SRPT) told investors that a meeting to discuss accelerated approval of the biotech’s lead drug won’t happen until later than he’d hoped, he told Mass High Tech on Friday that it’s nevertheless “not a delay.”
Chris Garabedian, CEO of the Cambridge, Mass. biotech, spoke on Thursday at the Deutsche Bank dbAccess Health Care Conference about eteplirsen, its drug aimed at the most common genetic mutation that causes Duchenne muscular dystrophy, or DMD.
Sarepta is seeking accelerated approval from the U.S. Food and Drug Administration for the drug, and the company’s stock fell in mid-April after Garabedian said the FDA required some more documentation regarding that designation.
Yesterday, it fell again when Garabedian said at the conference that “it looks like that the meeting that we were hoping to have calendered by the end of June... (will) be calendered in the third quarter based on (the FDA’s) checking with scheduling and also their need to take their time to review with teams internally.”
But on Friday, Garabedian told Mass High Tech that there has never yet been a date confirmed by the FDA.
“I wouldn’t call it a delay,” he said. “I was optimistically thinking that if (the FDA) was willing and able... that it would be by the end of the second quarter.”
Sarepta has now submitted the requested documentation, and “they need a certain amount of time to revie
Chris is missing something. Who requested this meeting? When was it requested? The last thing actually published was that the FDA needed the white paper summaries before they made a decision on AA. They just got the summaries so why would they need a meeting before they knew whether or not they would have any further questions? Is Chris saying that Sarepta is requesting the meeting so they will find out the FDA decion before it is made public? He is very unclear about this meeting.
maybe chris did get notified by the fda that given their schedule, time constraints and having to look at this new data, a response may not come until the 3rd quarter. it really may be that simple where the fda is just so busy an immediate response in the 2nd quarter is not feasible. if that's the case then it's not a reflection of the fda's hesitation to approve. they want to review the data and give it the time necessary to make an informed decision. from what has been tweeted around over the last day or so it appears it really is just simply the fda is extremely busy and may not be able to respond immediately.