From the ASX release on request for more info. I read that at the time to mean it may be less than 90 days.
I think technically the FDA can respond before the end of the 90-day period, but I think in practice they usually don't.
BOT had a recent experience where they were anticipating approval of a NDA and the FDA had 'up to' 6 months to review the application. The FDA literally went down to the last day to only advise that the container instructions needing improving. An issue you'd think they could easily report on well before the due date.
I expect the FDA stick to the full timeline lest they cop allegations of favouritism if they can get one company's decision out early, but not another's.
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- The Final Charge , Phase I/II MND Results & FDA ODD Approval Catalyst
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