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Re: longfellow95 post# 279594

Friday, 04/24/2020 2:51:57 PM

Friday, April 24, 2020 2:51:57 PM

Post# of 700289
Thanks for the advice longfellow, but I was obviously posting that article in relation to NWBO and their potential new drug launch next year in this pandemic environment, which won’t be going away for a while. We know that COVID-19 is pausing new clinical trial enrollment, which doesn’t really affect Northwest Bio right now, but it may have an affect on pipeline development in the near future, and potential new partnering trials.

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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