It depends if the approval is with restriction to certain population and with post approval study for safety, if so S/P will be 5-6, if without the S/P will be 7-8. I do think FDA approval will be conditioned on post approval study as to placate the GSK consultant who chaired the advisory committee and cast the ONLY negative vote for efficacy and raised questions about safety. Ethical/professional conduct is in short supply these days!