Agree I can't see why all the fuss over this. The previous trials had shown 2 x 2 mg to be effective, the FDA just wanted to know if lower doses would have same effect. So they asked for the lower doses to be trialled. Was found they weren't as effective.
There was already results for the 2x2mg Not sure why they then don't just accept the 2 x 2mg for major trial as they have found lower doses not as good.
If after we did as they requested they now do want another test, maybe because they caused this fuss then the FDA should pay for it lol
Ann: Paradigm Receives $7.36m R&D Tax Incentive Refund, page-52
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