how is it going to look for the FDA when UK and Canada approve this therapy while FDA denies. Folks will immediately ask 2 questions? Is it effective and is it safe?
Is it effective? Yes
Oh my then it must be dangerous is that why you denied it? No its also safe, you might get a slight headache from treatment
umm ok then why did you deny? deep pockets asked us not to approve
if there was a trial design failure, as what ex asserts, then we would have already learned that by now. There is none. The SAP has been bought in by the FDA they did not hear anything back. All we need to know now is if the data is good, which we know it is.