Hi @Bouncing
The next trial that will start later this year, is an adaptive 2/3 trial for which the FDA has already advised they will consider accelerated approval at the 24 week mid trial results. This I understand is reliant on gaining Orphan Drug Designation status. The shelf life is also considerable so making a bulk batch will not go to waste.
Cheers
Ann: PharmAust makes Head of Manufacturing appointment, page-9
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