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11/17/22 5:59 PM

#534459 RE: dr_lowenstein #533666

_lowenstein,

Dr. Linda Liau commented about trial design, crossover and FDA input with regard to this. Go ask Linda if you want more validation. Orphan disease status would include interaction with FDA on trial design. No surprise to them. Very old news. Feel free to ask peer reviewers for JAMA too. I am sure they can adequately put your concerns to rest. Best wishes.