PER 0.00% 7.7¢ percheron therapeutics limited

If this is correct, and ANP are successful in that timeline, it...

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    If this is correct, and ANP are successful in that timeline, it would be a masterstroke @P3COrion

    Reading the tea leaves back in June, I suggested that accelerated approval could follow Part A of the Phase IIb study with Part B serving as the confirmatory study, or in the parlance of the recent ANP presentation, the Post-Approval Commitment - refer Post #: 68209184. The presentation outlines the multiple pathways to market that includes firstly, Full FDA Approval and secondly, Accelerated Approval both stemming from the Phase IIb Study. The point would appear to be that if FDA Approval is a potential pathway from the Phase IIb Study which would presumably follow Part B or the Open-Label Treatment Period and Follow-Up Period, then the timeline for Accelerated Approval must coincide with an earlier period. Does this confirm the potential for an Accelerated Approval following Part A or the Blinded Treatment Period?

    In that case the timetable for approval and the award of the PRV could potentially be close at hand given that the Blinded Treatment Period will conclude 6 months from the final enrolment. Heading back to the announcement from 8 June 2023, it was reported that results from the initial 24 week treatment period were anticipated in mid-2024. Undoubtedly there will be some slippage, there always is.

    It doesn't mean it will happen only that it could happen and that is the masterstroke.
 
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