Mischaracterization of the FDA processI've read many times on this board, that we have to wait for the FDA decision about the filing for Phase III, that this may extend past a month. I think this is a mischaracterization of the FDA process. The filing we are talking about, unless I'm mistaken - and I'd love to be corrected then, is a Commercial Investigational IND, which includes many parts, among which a protocol for trial. The FDA doesn't have to explicitly validate it for it to take effect: it's automatically valid 30 days after filing if the FDA doesn't say a thing. So essentially, it's opt-out, not opt-in, and conversely, the FDA *may optionally* give it the get go before the end of the 30 days. See: https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-procedures-overview Quote: "An IND application may go into effect: -30 days after FDA receives the application, unless FDA notifies the sponsor that the investigations described in the application are subject to a Clinical Hold; or -on earlier notification by FDA that the clinical investigations in the IND may begin. Once an IND application is in effect, a drug manufacturer may ship the investigational new drug to the investigator(s) named in the application."