FDA said SRPT filing is prematured is not a sky-collapse for SRPT. They still do more tests and apply later. This is investor overreacting plus short selling. Wait a couple of days, SRPT WILL recover substantially. This is really buy opportunity.
Not cheap enough for a one drug company that may never get approval. Way too many other drug stocks out there to buy. This one will continued to be dumped by Funds and Institutions for year end tax loss selling.
Disagree. The FDA has made it nearly impossible to actually gather meaningful data by casting doubt on the Natural History, dystrophin production being linked to clinical impact, dystrophin quantification, etc. SRPT now has no method to measure Eteplirsen's impact that the FDA is willing to accept. How can you run an effective trial, if the FDA will not agree that there are acceptable ways to measure the drug's impact? Why not tell GSK, before they incurred the expense of a full P3 trial, that regardless of the data they obtained, the FDA was going to deny approval because there is NO ACCEPTABLE way to measure a drug's impact? The FDA appears to be lost, and unwilling to suggest acceptable ways to assess this, or any DMD drugs effectiveness. What a mess.
I think it boils down to the FDA wanting a placebo controlled trial after Drisa failure. The only way they could get this was to deny any attempts at a faster path. I think CG's crazy to suggest it only delays approval for 2 yrs.