RE:RE:Mischaracterization of the FDA processI'm sure they want the FDA to be in agreement, but this is the role of pre-IND consultation programs, it doesn't affect the timing once the filing is done. I just mean to say: there is no big "decision" or "approval", just a remote possibility of the FDA walking against it's own guidance by answering by a Clinical Hold before thirty days.
SPCEO1 wrote: While it is true a company can start a trial without the official approval from the FDA, uner the circumstances of TH's NASH phase III, I suspect the management and board of directors of TH would like to know the FDA is on board with their approach before spending $70 million or more to do this particular trial. I imagine they would want some indication that this trial would be viewed as a trial that could lead directly to an approval (followed by the phase IV trial to confirm). So, having the FDA being in agreement with what the company wants to do is critically important I suspect, even if it may not be technically required.
Spartrap wrote: I'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."