Hey Kwaidan1 I'm sure Pete wouldn't put anything absolutely specific as 30 days when talking of FDA. P.S would have given an indicative timing only and with a very large caveat that FDA has been very unreliable on any timings during the process, I have talked with him ad nauseam about FDA and timings. Firstly we had the month on month delays as to when they were to turn up and inspect the fill/finish facilities, this went on for over 6 months of them delaying.
Luckily for us we have seen the back of that and now only wait on them (FDA) to give the all clear to the CMO inspected facility and then get on with our actual filing and approval, remember there were a few different drugs being inspected on the same day at that same facility so it's not and wasn't all about Fonda, so a few days or weeks extra wont kill, well I hope not, I really need that celebratory drink:)
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