Denial, I have speculated in the past that the removal of the 2mg dose may have been due to the strength of the data for 005 and 008 and ethics committee (always a final step to approval a trial) suggested the optimum dose was not warranted in the dosing stage as the pre-existing data was satisfactory to compare the dosing stage data against. The term used here on PAR announcements are “pre-determined threshold”…… my question is who was involved in the pre-determined threshold discussion. But, ofcourse I could be wrong as no one really knows. I have other ideas here too like to pharmakinetics studies at 1.5mg and the 2mg were so close to be equal that again ethics encouraged removal of the higher dose. BUT, this molecule is special and I truly believe PAR have landed on the optimal dose at 2mg. I also believe Ravi could explain this better than any one the planet.
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