Thanks @Mangoman605.From my perspective the staged approach...

Thanks @Mangoman605.

From my perspective the staged approach whilst protracted help mitigate the risk of missing primary end points and the end of 002-003. Stage 1 has now confirmed 2mg/kg x 1 and 1.5mg/kg x 2 is NOT the minimum effective dose. The known and preferred dose used in OA008, 2B and SAS of 2mg/kg x 2 is both effective and still SAFE. Interestingly also the combined n for these prior trials using 2mg/kg x 2 all showing statistical significance on primary end points being used on OA002-003 is greater than the proposed Stage 2 n.

So we now wait for FDA to confirm we're good to move to preferred and known dosage of 2mg/kg x 2 for Stage 2.