NorthWest Biotherapeutics Inc (NWBO): The mfg facility can be outside of the U...

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NorthWest Biotherapeutics Inc (NWBO)

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Re: skitahoe post# 523608

Thursday, 10/20/2022 5:53:02 PM

Thursday, October 20, 2022 5:53:02 PM

The mfg facility can be outside of the US for US NDA/BLA. And the FDA will inspect the facilities and not rely on any other RAs. GMDA and SPPI are two examples.

https://investors.gamida-cell.com/news-events/press-releases/news-release-details/gamida-cell-announces-fda-acceptance-biologics

https://www.businesswire.com/news/home/20210601005315/en/Spectrum-Pharmaceuticals-Announces-That-the-ROLONTIS%C2%AE-eflapegrastim-Pre-Approval-Inspection-Has-Been-Initiated

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