Replies to post #559434 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

But yet NWBO hasn't filed an application for MHRA approval required for commercial sale.

61 months since this PR

“Now that the data from our Phase 3 clinical trial of DCVax®-L have further matured and provided a further encouraging picture of patient survival, and we are ready to move forward with the months of work related to completion of the trial, we are very pleased to have a new war chest of funding for this work,” commented Linda Powers, CEO of NW Bio. “We are also looking forward to proceeding with further DCVax®-Direct trials.”

[SkyLimit2022]

Yes, I think that’s right. We probably won’t know about it until it has been submitted, posted, and announced in a press release.

https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847

https://www.nice.org.uk/guidance/indevelopment/gid-ta10143

https://nwbio.com/press-releases/

[biosectinvestor]

Obviously they are workin towards it, having filed the key appendices to such applications that have to be completed first. For a living product, that is highly customized, like this one, commercial manufacturing is likely the largest hurdle other than the clinical trial evidence. Clearly they are immersed in the processes of regulatory applications and advancing their commercial manufacturing.