It has surfaced the news that the CEO of SareptaTherapetics (NASDAQ:SRPT), Chris Garabedian, has been kicked to the curb by the company’s board of directors after his consistent urges to undertake a combative sort of relationship with the FDA.
With the CEO leading the company, many attempts had been taken on getting the drug Eteplirsen approved with just a few mid-stage trials being carried out along with a thorough follow up study. Initially, the FDA had tanked this idea back in November of 2013; however, afterwards, it made sure to delay the regulatory filing of the drug last October while citing any doubts of the company’s collection of data to estimate the dystrophin amount being used in production for the treatment of boys using the drug.
Afterwards, the CEO blamed everything on the FDA as it delayed the drug’s progress which caused somewhat of a riot. The relationship that the CEO had with the administration was a problematic one, which caused the board’s course to change altogether. The result was an extremely volatile price per share which has continued to fall for quite some time now.
It was stated in a press release that Ed Kaye, the company’s Chief Medical Officer, is going to replace the CEO but only for the interim period. The important thing to note here is that the company is still planning on submitting its drug for the approval of the FDA somewhere in the middle of the year.
So the question you might be asking right now is what investors should consider? The answer is pretty simple. If the drug is able to succeed in the regulator part of its journey then it can expect to ride a blockbuster roller coaster. This is the reason why a premium was paid by BioMarin (NASDAQ:BMRN) for its candidate of DMD and Prosensa in just the previous year even with the shaky sort of clinical profile that it had.
However, the problem is that DMD drugs have failed in trying to impress the six minute walk test which is a gold standard measurement in the clinical world. The problem was that patients who were treated with the therapies showed a huge range of variability for the measurement even with an increase in the dystrophin levels.
Therefore, the company has been lobbying the FDA ever since so that they may accept the production with dystrophin production just as a means to reach the end which could help in its approval. However, a workshop by the FDA that just took place showed the market that measuring the levels of dystrophin still remains a work-in-progress which shows the concerns that the agency has for the company’s clinical data.
It still remains doubtful that there will be an acceptance anytime soon by the FDA. However, on another note, the company was pretty good in walking stabilization when considering its intent to treat analysis at the 96th week for patients using the drug.