I think the last two days are likely the CRL SRPT got from FDA. It was unexpected and at least to me, the reasons seem confusing. There is less confidence in FDA acting rationally by investors than two days ago.
Of course I’ve been on the “not trusting” side for a while now. Logically, our approval should be based on the companies manufacturing facility inspection which I expect has been brought up to and exceeding all that FDA has asked.
The question is, like us the first time around, and SRPT yesterday, is FDA withholding communications on important items from the company that they will then use to issue a CRL? I really don’t think so, but the selling suggests there’s more of a concern since SRPT’s CRL than there was before. |
