Replies to post #505781 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

The pasted quote in your response is from you. It would be outrageous to think they are feigning intent to file an MAA before manufacturing cert decision. If your suggestion is they intend to file a vestigial MAA simply to get a manufacturing cert., that too would be outrageous and nearly certainly incorrect. If your point is simply you don’t have to file an MAA before a manufacturing licensing decision is made, wherein the basis of application is a new product, I still say you are incorrect.

[Doc logic]

FeMike,

You are correct but.. they would only get the license based on the need to have one for commercial scale production of some product. If that product was for anything other than DCVax-L initially, NWBO/Linda would be in serious trouble since Sawston, unlike Cognate, did not significantly contribute to the trial process to benefit NWBO shareholders and Specials certification is a lesser cert. Sawston must be certified based on DCVax-L commercializtion or the blowback on Linda/Toucan would have teeth. They won’t go there without serious repercussions hence they won’t go there. Therefore, speculation that Sawston would be approved commercially without a focus on L is speculation without any serious merit. Best wishes.

[dennisdave]

In the meantime I will maintain my position that DCVax-L MA is not required for Sawston to get commercial certs.

Ofcourse Advent Ltd legally does not need DCVAXL to get approved in order to get their MIA license, but commercially and financially there is no way Advent will survive without DCVAXL approval.