After a dosing arm of a trial - normally a pharma doesn't need to go running to the FDA to move into the selected dose (even the trial protocol says that) - unless the FDA may have a problem with what you want to do.
Just saying.
Learn FDA protocol. And stop saying the drug impacts DNA because some non-medico private citizen of Otago, New Zealand said it in a discussion paper.
My conclusions are founded in a more robust inquiry.
Where we at?, page-691
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