Replies to post #573503 on NorthWest Biotherapeutics Inc (NWBO)

[$mith$on13]

I imagine there are plenty of other places one can deploy capital at this point, if the perceived timeline here isn't agreeable. :)

[flipper44]

However, LP strongly suggested this time around there will be favorable combination trial agreements associated with MAA progress. If so, that will likely change the scenery.

[X Master]

If it were not for LP and LL this trial would have died many years ago. Granted, if Big Pharma was driving the bus after the Phase 2 results were in we might have got through the approval process quicker. However, BP was not interested in such a laborious lab process. All they wanted to do is crap out a golden cancer pill or a uniform liquid like Keytruda. Custom therapy was taboo. So this therapy would have died a quick death.
So while you are correct, your hypothetical scenario would have never come to fruition. So whats the point?
We are left with this tiny company pushing the Bus while the market makers throw rocks under the tires. This said, I have no doubt all 4 RA's will approve DCVax-L. It's only a matter of time.

[skitahoe]

Maverick, you're right if they had a way to make the product commercially, that's been on the critical path for years. As I remember it they only acquired FlaskWorks in 2020, they knew it would require work to make it suitable to commercial production but nothing else exists that can do it other than every batch having to be made individually in its own cleanroom.

I really don't think many companies would have invested in thousands of tiny individual cleanrooms knowing they had an automated method for doing the process where numerous units could be located in a lower level cleanroom.

I have no idea when NWBO first learned of FlaskWorks, nor do I know how long they were negotiating for it, I think they got a tremendous deal at a bargain basement price, but they may have been the only company that needed such a device at this time. I know that other products are made in cell lines in cleanrooms, I cannot say how many others may be adaptable to use of the FlaskWorks units. I believe that over time FlaskWorks will become its own profit center for applications outside of DCVax-L and Direct. Wouldn't it be great to make money from developers of other personalized drugs who're paying for a unit developed by FlaskWork to make their product.

I believe that years ago I indicated that commercial production would be the critical path to approval, I had no idea how long it would take, but felt that all the paperwork that had to be done could be done before they had a production facility ready for inspection. Even with manual production at Sawston it was on the critical path. Sure, if more money could have been spent Sawston could have been ready sooner, but probably not more than a matter of months sooner.

I would suspect that if DNDN had developed a unit like the Eden while they were in the approval process they'd still be in business today. I cannot say that unmodified the unit could make Provenge, but I suspect it's technology could be adapted to do it. I know people who made, and lost, a great deal of money in DNDN, I never owned the stock, but did lose out on a small call option that closed out of the money when FDA delays were announced. For all I know a device like the Eden unit didn't even exist in anyone's mind back then, or perhaps Provenge provided the genesis for its development. I don't know if S.M. knew of DCVax's at the time he set out to build it, or if he saw the need for something to create personalized products in an automatic way and it was fate that put the two companies together.

If I'm correct about a worker needing to completely change outerwear when moving between individual cleanrooms I hate to think of how many changes would be required a day when say 1000 such cleanrooms are operating simultaneously. At roughly 50 batches a year that's only 50,000 patients a year that could be treated. You can imagine how many cleanrooms would be needed if not only GBM had DCVax-L as part of the SOC, but other solid cancers as well. I'd love to have had the concession for all the cleanroom outfits that would have been needed.

Gary