I think it's possible that PAR could go to the FDA to request they use 2mg/mg twice weekly, but based on the trial design for 002 and 003 it currently appears they can only use one of the three dosage regimes used in stage 1. It would be good to get clarification from PAR on this.
In saying that, 002 and 003 are powered to achieve statistical significance. If we had a 2mg/kg treatment arm then it would almost seem all too easy.
Ann: PAR Reports Successful Primary Endpoint in Phase 2 Trial, page-48
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