About Duchenne muscular Dystrophy treatments, bloggers tried to explain the reasons that led the FDA to decide upon reviewing BioMarin’s (BMRN) Duchenne muscular dystrophy (DMD) drug Drisapersen a few weeks earlier than reviewing Sarepta (SRPT) DMD drug Eteplirsen.
The real reasons for the FDA decision remain inside the FDA mind. No outsider will be allowed to know anything related to NDA reviews. All the talk and writings by those who favor one over the other of the two firms is mere speculation that might have nothing to do with mere reality.
Currently, the only recognized fact is that until the two meetings take place and the FDA announces its final decisions decides, Sarepta will continue to be the more vulnerable party to negative speculations, as it is the one that has the product to be reviewed last, rather than first.
Our educated guess is tilted to make us feel comfortable with the following possibility: BioMarin inherited its drug Drisapersen after it has accomplished all the clinical trials. This fact makes us reach a conclusion that the data presented by BioMarin is more complete, hence help the agency or its advisors find reasons for approving the drug (or both firms’ drugs) than going over Sarepta’s incomplete data that might stop short of enabling the regulatory agency to get to the true picture of how these drugs would help, how much they would help and the possibility that the positive impact might increase over time.
One must not forget that the FDA has looked carefully into BioMarin drug Drisapersen results before the company filed for approval. As a matter of fact it was the FDA that encouraged BioMarin to file for approval in spite of fact that Drisapersen had failed to reach statistical significance and there must be a good reason for the FDA decision to encourage BioMarin to file for approval. The same scenario occurred later between the FDA and Sarepta.
One could also consider the fact that BioMarin has filed NDA for Drisapersen approval a couple of months before Sarepta filed for the approval of its drug Eteplirsen.
Bottomline, the review dates might not have anything to do with the approval of the DMD drugs per se, but it is doing a lot with the bearish and bullish bloggers and their influence on their followers.
Our feeling, which is just a feeling, is that both drugs might receive approvals and in the worst case scenario they might be granted conditional approvals.
Good news for both firms is that their far-reaching technologies have demonstrated success is producing the protein dystrophin whose inadequate availability is recognized to constitute the root-cause of Duchenne muscular dystrophy.
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