As alluded to in another thread, there is a much larger P3 trial requirement. A second trial that will run in conjunction with the first. Over 1,000 participants in total.
Primary and Secondary end points have been agreed to.
WOMAC scores for SAS patients have been published.
I don't think there is any funny business here - FDA minutes were provided to PAR, dictated a larger trial requirement, PAR want to make sure they are covered for the larger trial and OPEX for 2 years.
Ann: Voluntary Suspension, page-18
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