RE: When the CH is Shifted, the Brakes on HEMOs SP will be lifted.31 Jan 2024 12:55
So the RNS of FDA submission of the one outstanding issue was 7am on Tuesday the 16th but I believe someone (Haywain perhaps) has clarified that the FDA's 30 days starts from when they informed the applicant not the applicant's RNS. So was this before 7am on the 16th (maximum 10 working days left) or the 15th (max 9 days) or the Friday before in which case only a maximum of 7 days?
(Or going off the 23 days the FDA took to respond last time to the whole submission, that's 5 or 4 or 2... ) Or sooner of course :)