Friday, April 24, 2020 2:51:57 PM
One of the questions I would have asked at the ASM is: what impact is the coronavirus having on reaching data lock and topline (if it wasn’t already announced), and what impact do you anticipate it will have on the approval process, potential launch, and partnering trials?
I guess we learned that it’s slowing the process somewhat, but there are work arounds. Since the actual filing of the BLA and MAA , etc., are electronic, and the meetings with regulators are virtual, that part won’t be affected, but pre-approval inspections, and regulatory timelines could be backed up for months.
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