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02/21/20 3:17 PM

#266505 RE: laser777 #266481

laser777,

Faster to market perhaps with multiple other indications, maybe. Don't forget the possibility of a rolling BLA and the potential importance of this SAP with regard to shortening future trials. Linda will weigh what they can do with a partner against how quickly they can ramp up on their own with Cognate, Advent and new guidelines. She knows how to make deals and use leverage. Best wishes.

monentum2play

02/21/20 3:18 PM

#266506 RE: laser777 #266481

I am all for it. Commercialization is harder than running a trial
That would be the smart thing to do.

hyperopia

02/22/20 12:37 PM

#266672 RE: laser777 #266481

Hey laser, long time huh? Good to see you’re still around.

I’ve been thinking about all the quotes that I’ve read from Merck executives over the past couple of years and the type of assets Merck was interested in acquiring, and I’m sure that if this trial has positive topline, and Northwest Bio presents very compelling full data at ASCO, that Merck (and other BP) will be extremely interested. I’m not so sure how interested Northwest Bio is in partnering at this point though. I would sure like to be a fly on the wall during those discussions.

I think that manufacturing in the U.S. is ready, and nearly ready in the UK, and Linda is prepared to file a BLA, NDS, and MAA, and take DCVax to market on their own, and is not looking to partner DCVax for glioblastoma. From Linda’s point of view, she could use BP’s money and regulatory expertise, but it may not be worth cutting them in because Big Pharma has little cell manufacturing capabilities, and DCVax would still likely be manufactured by Cognate and Advent who are familiar with, and have automated and industrialized the process for commercial manufacturing. In addition, BP’s large sales and distribution infrastructure is not really needed for a personalized treatment that will initially be distributed through the few hundred neuro-oncologists and medical centers that participated in the trial and are familiar with DCVax, which could easily be handled by a sales force of under 50, perhaps even 25. With an approvable cancer treatment and credibility reestablished, and an uplisting on Nasdaq, I think Northwest Bio will be able to attract favorable financing, which would give Linda considerable leverage if negotiations become serious later this year.

I have wondered why Northwest Bio has not started any of the clinical trials that they have talked about last year. Is it really because they don’t have the financial resources or perhaps another reason? If DCVax proves effective for glioblastoma, I have to believe that Merck would like to run hundreds of trials with DCVax, both as a single agent in multiple indications, and in combination with Keytruda, and they may not have the patience that we investors have had with Northwest Bio’s clinical development plan or pace. From Ken Frazier’s most recent public comments at the JPM Conference, it seems Merck may be able to justify paying a high price for just such a platform technology. Should be interesting.