Can I ask you why you are confident that the 2mg twice weekly will sail through the FDA?From reading discussion here, it seems highly likely that the FDA will request a re-run of the dosing study given that 2mg twice weekly was not included. I can’t see them allowing a dosage for which they don’t have data available. Just in terms of due process, they will make PAR cover it off if PAR wishes to use it. For the record, I hope you are right and I am wrong.
AGM 2024 - QUESTIONS, page-52
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