Friday, December 03, 2021 2:19:29 PM
And we all have theories on manufacturing. I'm in the they don't have a current contract w CRL for US manufacturing of 'L'; either because 1)they were tired of paying for dedicated space when they knew it would be a while for 'L' to reach the marketplace (and LP not having a vested interest in CRL like she did when she was paying for dedicated space previously) and/or 2) they'll resume w CRL once they start the BLA process. In the US, as part of the approval process, the FDA will do a pre-approval inspection prior to approving the BLA and that usually happens towards the end of the review process. Maybe that will be enough time to restart CRL DCVax-L operations, and/or 3) NWBO has been spotlighting Sawston. Perhaps they will be manufacturing for the US too. I feel like 3 is a strong possibility especially if they feel that Flashwork manufacture is ready for the big time.
Yes conjecture, and I really feel strongly regarding the BLA not being submitted (I'm sure they are working internally on it), but that's how I see it.
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