Replies to post #433794 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

I do not think manufacturing is holding up approval. I think the FDA’s updated policy is holding up the ability to announce TLD in the US, and that inability to finalize data because the policy providing the framework is still in draft form has them focused on other markets. Just my opinion.

I do not think manufacturing is holding up anything. I do think they need a practical plan to meet demand to get invited to participate in Project Orbis, but the way the FDA is going, Orbis may not be all that important if they get approval elsewhere first. The UK has the commonwealth and Canada and Australia are part of that.

It seems to me that they will be initially focusing on the MHRA while the FDA gets its act together. But who knows, the FDA could do it’s job any day now.

[flipper44]

I think it’s slightly more overlapped. Dr. Pazdur has reminded the world that any new Incoming SOC must have the ability to ramp toward increasing demand. With all due respect to the manual operations, imo, once the results and approval are (likely) given, demand will quickly outstrip manual production. I mean really quickly, imo. So they’ll at least need to have a green light for the automated version before the demand far outstrips supply, because, imo, results and approval in particular will not be bandaged by GoFundMe’s. Manual would be like sticking a finger in the dyke to stem an impending raging torrent. LP has essentially led us to believe manual is really only for the specials program, I’d guess some overlap during transition to commercial.