Ok thanks Wizard. I'm just confused because the last announcement said there's nothing more to be added apart from labeling.
Human Factors study FDA will need to do?? huh?? Thought it was just a simple "can people understand" instructions test done by BOT. Human trials has all been completed.
Anyways, we'll see what January says when resubmitted![]()
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- Ann: FDA Confirms Approach to Sofdra NDA Resubmission
Ann: FDA Confirms Approach to Sofdra NDA Resubmission, page-74
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