Replies to post #53769 on NorthWest Biotherapeutics Inc (NWBO)

[DoGood_DoWell]

Longfellow -

Great response. Also, what about all of the manufacturing innovations and patents which enables the mass production and mechanization of DC Vax. Isn't the new facility being designed with that in mind? From what I have read previously on the board, mechanizing the process will save significantly on manufacturing costs, as well as allow many more doses for more patients to be made. That reduced cost per patient and mass production will make many of the obstacles Rk mentions disappear. It remains to be seen whether a combination will even be necessary once patients can start sooner in their disease progression, have optimal maturation method, optimal timing, and injection of more than one tumor. The costs that are being estimated now are based on very low production numbers and higher relative costs to manufacture. With volume, fixed costs become lower with each dose manufactured, and leukapheresis costs will likely reduce as well.

[Rkmatters]

I didn't say that there was a part of your post that I didn't understand!

What I did do was correct this statement of yours:-

'But nope, no checkpoint inhibitor as of yet. Only mentioned a discussion a year ago. Nothing has become of it'

I referred you to the companies presentation of last month, where it was pointed out that two of the five conclusion points related to CI's.

So, it is still being mentioned, and the door remains open.

A question for you. What do you mean by 'they want to partner'?
Are you referring to the CI manufacturers, or are you referring to NWBO?
How do you know 'they' want to partner? Is this supposition?

Despite what you are implying with comments like 'I wouldn't hold your breath.....over a CI collaboration' I have an open mind about whether it is the right way forward.

I can see pros and cons. At the moment, I am just stating that it remains in the frame, and the fact that it was mentioned by NWBO only 2 or 3 weeks ago indicate that it remains in their thinking.

You have no idea what is going on behind the scenes. There may have been lots of partnership discussions between NWBO and BP. There may have been none. I have my own hypothesis on this.

Yes, of course it's a long road to approval, and yes two therapies will cost more than one. I think I had managed to work that out.

Whoever said it would be easy?!!!

If you're adding context to my comment, to me that implies you didn't understand it. At this point a partnership talk(s) with a checkpoint is speculative. They, as in NWBT, by adding it on their slides, are very much interested in pursuing the idea of a CI combination. Of course it remains in their thinking, they would like to Partner. BUT, as far as big Pharma being interested enough to partner is bogus. DoGood suggested might be coming down the road, in an ARM of a study no less. Evaluate asked to see a link of the study. AND so I replied as well DoGood charter is speculative!. NWBT has never mentioned anything about a trial design with a checkpoint inhibitor. And they also made no mention of big Pharma being interested in pursing more than a talk. NEVER once was it suggested that big Pharma approached them. Instead it has been NWBT in their talks and on their slides about why their product would make a good partner with a CI due to their MOA.

AS far as the door being open, it is can be open wide, but that doesn't mean anyone will come inside. So if you want to hold your breath over the idea that a COSTLY, UNTESTED, DIFFICULT to MANUFACTURE (patients may need a few leuks; product is personalized in a clean room) DCVax-Direct + CI combination and collaboration is coming, then you by all means do that. I advised you not to, but I won't again. Yes, it would be wonderful if they can make it happen. But I remain skeptical as to the likelihood before proven technology or lowering cost and ease of manufacturing (see prior post). I obviously think it's a good idea if they did, otherwise I personally wouldn't have sent them a clinical stage CI option avenue to explore.

Again, I'm not investing because I think the road to regulatory review as a mono-therapy will be long and challenging one. I do think the prior results warrants a Phase II testing, for reasons I've mentioned in the past. DoGood's post highlights some of them. However, I do feel that phase I preliminary results should have been much stronger. The fact that it wasn't, I'm on the sidelines. I don't see a combination on the near horizon. No pharma in my opinion is going to be interested in spending millions and millions of dollars partnering to test with a product that did not show ORR efficacy, and whose supposed long-tail survival will be impossible to credit entirely to NWBT given patients failed therapy early on. And, not to mention, they're unable to lift the trunk to look under the hood. In my view, they can put all the CI they want on their slide but they'll still have a hard time attracting a partnership IMO unless they do the other things I mentioned in my prior post. GL