Replies to post #803703 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

dennisdave,

While I agree with you about this concern, I believe MHRA will only require a good faith gesture with a GMP, initially validated manufacturing unit because of the importance of the product meeting an unmet need. This is speculation, of course, but NWBO has stated that MHRA is and has been working closely with them. The other way to gain UK approval would be to only approve for GBM orGBM with artisan as a kind of boutique approval then seek approval with Flaskworks for everything else later after full commercial scale validation of Flaskworks. That would not be the best for patients or investors but would likely meet the pathway standards you are pointing to. I’m pretty sure they have already thoroughly discussed this. Best wishes.

[CaptainObvious]

IMO, if the artisan method is intended mostly as a backup, it is still 'in production'.

[underpar71]

You have to understand one thing. They applied for two indications and with one manufacturing process. That's it. That is all that is being reviewed. "Regulators" will feel misled? Bogus. Adding another manufacturing process after approval....two+ years after submission while perfecting it, is not an issue.

[Smitty5150]

“

We generally cannot grant an MA based solely on the original process if the applicant no longer intends to use it.”

NWBO plans to use it, at first. Sure, Flaskworks is the future, we all know that, but the freaking device isnt even ready yet (and now we now know of major delays building it because of the lawsuit with the Co from Massachusetts) neither are the rooms needed to use them. I suspect none of this (FW and CS) will be ready until 2027, given the past performance on NWBO meeting timelines on such issues. Its at least a year away. So yes, the current manufacturing method with be used for at least a year.

[sentiment_stocks]

“The MA must reflect the intended commercial manufacturing route.”
“We generally cannot grant an MA based solely on the original process if the applicant no longer intends to use it.”

And the MA does reflect the intended commercial manufacturing route, and they intend to use it.

And when they want to move to Flaskworks, they will take the appropriate steps with the MHRA to do so. In the meantime, artisan is how they'll make DCVax-L.
Period. End of Story.

We get what you think as you have made it VERY CLEAR, and practically none of us agree with you, including the company.