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Re: jessellivermore post# 220177

Saturday, 10/19/2019 2:55:33 PM

Saturday, October 19, 2019 2:55:33 PM

Post# of 427711
Good summation. It does appear though that, based on previous FDA actions, there is always the chance that the FDA once again admits a mistake, this time regarding considering MO an inert placebo, and the ADCOM is about whether a DDI is necessary. I just don’t see any other potential negative reason for an ADCOM (if not the MO issue, then it’s all about label expansion). How long would a DDI take to establish certainty about MO interaction?
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