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Re: Bob_LobLaw post# 423538

Friday, 12/03/2021 2:19:29 PM

Friday, December 03, 2021 2:19:29 PM

Post# of 727362
You're right, Investors do not know, and us investors know that, but I would think they would PR good things like if they submitted a BLA. Regarding TLD, sure they have it but they wouldn't keep it secret if they are working w the FDA et al. Isn't the whole point of submitting a Journal article is to clarify and explain to the Journal audience, which the FDA et al is a part, the significance of DCVax-L TLD? Why would they submit TLD info to the FDA et al before that? It doesn't make sense to me.

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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