I reviewed an email that was sent to me by some time ago by the FDA in which it clearly states that the FDA does not "approve" clinical trials. So anyone can submit an IND but no work can start before the 30 day review period is up, during which time the FDA can suspend or deny any such trial. If there is no FDA action in that review period the applicant is free to start the trial.
As far as the clinicaltrials.gov registration is concerned the trial must have a sponsor and that entity (where an IND is involved) has to be the IND holder. I guess they may allow a registration with the expectation the sponsor entity shown on the application will become and IND holder.
So whether Tacere is already an IND holder or not, it looks like we will be recruiting in August for a September start.
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