Yeah, I hope they don't screw us over. What is eve

Yeah, I hope they don't screw us over. What is even more questionable is that they sometimes send out CRLs with minor issues to companies that had special designations like orphan drug designation etc., although these are meant to facilitate communication and identify possible concerns early on in the (review) process. Sarepta is a recent example (though there is some controversy as to the efficacy of their product): no concerns during the review, even had label negotiations and then all of a sudden a CRL.