as it’s only pre-IND guidance the IND has not been resubmitted by the sounds of it, just resolved previous FDA concerns.
Based on DrT trial dartboard comments, it’s basically good to submit when a clinical trial or partner is ready to proceed with a trial, with a 30 day decision.
Also mentioned no plans to use in short or medium term, so reiterates my view that deal will be done prior to US IND, as this is the trial that is critical for approval.
Ann: Positive Pre-IND Guidance from FDA on Zantrene, page-58
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