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Re: sts66 post# 208874

Wednesday, 08/14/2019 3:44:57 PM

Wednesday, August 14, 2019 3:44:57 PM

Post# of 425888
sts66: He didn't have to. If I recall correctly, Thero said he did it on his own accord in keeping with the best interest of the investors, which I am assuming to mean transparency. As I pointed out in a previous post, if he waited for the filing in the Federal Register as the FDA requested, this could occur as late as October (which is inline with 6-8 weeks before the AdCom as indicated in the guidelines provided by MRC). The announcement would therfore occur well beyond the PDUFA action date and so any delay makes zero sense.

dmlcento: If you can provide FDA guidelines that refute MRC's, I would be happy to correct my statement. But for now, I am going to go with a copy of the FDA guidelines as "fact."
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