Replies to post #249937 on NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

Good question. The way you phrased it, do you suspect that Northwest Bio is making false statements in their SEC filings? I doubt it, and I also doubt that a major ramp up is in progress, but I do think that Advent will soon be ready to add to the manufacturing capacity, which should be sufficient for the initial commercialization. I agree that even the Big Pharma companies will often seek initial approval in one market before expanding, so seeking approval in 4 countries simultaneously seems aggressive. But in this case, if one market decides to delay approval for some reason, then there are still multiple other opportunities in the other markets. I have thought that the UK/EU with their Hospital Exemption and PIM designation for DCVAX, seem more eager to approve it than the U.S., and maybe I’m not alone. Or maybe another reason is to create a broader available market to increase the buyout price?

[exwannabe]

Well, Cognate says they were at capacity manufacturing for the P3 back in 13,14,15. That was about 100/year. At the time they had 6 suites. Now they have 22 suites.

So by one measure that would be about 400 patients a year. I could accept the actual number is higher as I think a dose is made in about a week and turning a single use facility around is fairly quick. So maybe 800/y US?

But Cognate is not NWBO, they have other customers. As of today, NWBO has a commitment for a single suite.

Nobody knows what is up in the EU and UK as Advent is a mystery (grown tired of Brexit, so do not know if UK is part of EU next year wrt this conversation).

IF (that is IF with capitals at the top of my voice) they see clearly approvable data they can quickly start to spin up large sites of their own or get other CDMOs on board, or sign a contract with Cognate/Advent to expand. DNDN took about 2-1/2 years to start getting their GA/NJ plants on line (from memory).

I would not fault NWBO at all for running the trial partially in the EU and Canada. I do think the difficulties are way overblown and they are using the "4 RAs" as an excuse.