Seeking Alpha " CEO Meeting w/ FDA End Of This Month for Accelerated Approval" LINK
Upcoming Catalysts For These BioPharmas Provide Potential Upside
February 20, 2013 By: Scott Matusow
Sarepta has requested an end of Phase II meeting with the FDA, which is likely to occur before the end of this month. The focus of this meeting will be the company's request for accelerated regulatory approval on its experimental drug Eteplirsen, which is designed to treat
Duchenne Muscular Dystrophy ((DMD)).
There are many Sarepta bears who believe the drug will not receive early approval, and in my opinion, they are not considering the ever changing political landscape surrounding the FDA. Lawmakers have been putting additional pressure on the FDA to get drugs to market which are designed to treat rare diseases. DMD is a very rare disease that affects children - providing additional pressure for the FDA to grant accelerated approval here.
I wonder if the bears have read Section 902 of The FDA Safety and Innovation Act - "Breakthrough Therapies."
According to author Michael Mccaughan;
The provision creates a new section of the FD&C Act, and inserts it directly before the "Fast Track" and Accelerated Approval sections also included in FDASIA. That symbolic position indicates the intent: something that happens even earlier in drug development than the existing FDA mechanisms.
Also, it will be hard for the FDA to ignore Jenn McNary, mother of a child who suffers from DMD, who has been one of many strong advocates petitioning the organization to allow accelerated approval of Eteplirsen.
The chart has just begun making a couple of reversal candles indicating a higher move is possible once it breaks out of its current wedge. After this point, the stock could retest its former high of $45.
Short sellers in Sarepta could get severely burned for failure to recognize the ever changing regulatory environment in the FDA these days. With Obama Care coming into sharp focus in 2014, we can also expect to see more small-cap biotechs rally on the speculation that they might receive more government support for their new treatments for terrible and deadly diseases. I also expect merger and acquisition activity to increase in the next year because of these factors. Biotech might very well be the best trading and investment sector for the next few years.