Webinar is good. It’s a delay. 3-6m
seems little to no concern.
no efficacy or safety issues.
market could get marginally larger in this time.
the requirement to resubmit is not complex.
they have cash. No cap raise it seems. Fully funded to reach revised approval date.
FDA takes 6m. But the time to complete resubmission is circa. 2 months.
Ann: FDA Letter Requires Patient Instruction Update, page-59
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