Transcript Big Biz Show Pt 2 Aug 18, 2023
This is one of the few Big Biz's where Les actually says anything newsworthy. The quote about order of RAs apps is in here, but also an interesting reply to Sully's partnership question near the end.
Sully: Big Biz Show continue with Les Goldman, Northwest Biotherapeutics, symbol NWBO. Les, I’ve got another question for you, so what so what is the next let's say six months, 18 months, five years outlook for Northwest Bio considering you just got back from ASCO, all the findings there you know you've sort of enumerated, you know kind of the eye-opening stuff that's going on here, so what's next? Are we going to continue the research, are we going to an FDA sort of arc of a story where we're getting close, because it's obviously exciting. I'm gonna get a million emails from people asking when can we get this here in the U.S so talk about that a bit.
LG: We do have this prevention treatment program and may need to go to the UK to initially get it made but a recent license we got to use our facility that we built for commercial operation and it's been licensed to allow us to ship anywhere now in the world, if you call our offices there is a backlog but we can still get a hold of it – we’ve got a waiting list at this point but more significantly we are in the process of finalizing our applications. The first one will be to the MHRA in the UK which is allowing us to do this specials program even before we file, but we're we're getting much closer to being finished up with 1.7 million pages long it's got 27 modules uh it's being double checked now to make sure that it’s completely consistent. So we'll be applying there, and we'll be applying then to the other places that gave us permission to do the trial, that was four different countries including the UK, including Canada, and including Germany and we'll be filing in order in each of those places for a commercial approval and then we will go into operation on a completely commercial basis.
I think the prognosis is very exciting and that we've shown the positive results in in in the compassionate treatment, specials program and we're also dealing with issues we're relating to our not as high as we believe we deserve, value in the marketplace because of interests that would rather see us not succeed; we're cheaper, we're more efficient, we're non-toxic. I would have to add it's already been shown that in combination with certain other products that have been produced which have no effect on solid tumor cancers we enhance the result of what we get when we put it in combination with others, and we'll be doing plenty of that as well.
We also have a product for inoperable tumors where we take the magic formula if you will, and together with MD Anderson in 2015 we ran a Phase I/Phase II trial where we developed a MRI guidance, or CAT scan guidance of being able to take a very thin needle and inject it to find the mothership tumor in a given body, and then put the stuff into the tumor with this very thin tube which is quite non-invasive, but can be guided by the things that you can scope, any one of the ways you could do x-rays. We got very good results on that and then we got the same safety results, which is basically no toxic side effects, and we'll be developing that product as well with further trials.
So there's a lot of activities lying ahead to move this first one, which was our lead item because frankly these trials all cost a fortune. For example if you're going to do prostate which we also have something that works on, to do a Phase III trial can take six or seven years and it costs $800 million. Unfortunately you die a lot quicker and you can measure the results much quicker with GBM so we picked GBM to be our lead, and we're getting we're getting near the end – others are working on it but we're the first.
Sully: Hey Les, last of all will you take this to the finish line or this is this one of those risk aversion models where a bigger Pharma company will come in and take it to the market or do you guys intend on taking the market yourselves once you get there?
LG: Well, if you're asking for absolutely everything, that would be a very big menu I think with our 70, with our 90 sites and 73 doctors we have a pretty established infrastructure for GBM. The fact that it works on other things means, I think it all depends on who might want to team up what they want might want to pay in the future.
Sully: Good stuff, thank you so much
AI
