BB,
What you're saying is completely true, but not truly complete. In my discussion with DI I indicated that the information that's been presented was what was agreed could be presented, the remainder is embargoed by the agreement with the Journal. To me this means that as long as they're maintaining their agreement with the Journal they cannot discuss what they've agreed to have embargoed. I believe this is the difference between well under 50 people showing in the K-M plots they've shown to date and the median survival for the Top 100 spoken of by Drs. Liau and Ashkan which clearly indicate that 50 or more are alive at 7+ years.
Certainly there is no requirement to have a JA, they could abandon this effort, but as long as they don't, they're bound by what they've agreed to embargo. Something else I believe this should be telling us is that they are dealing with a single Journal who's set up the terms of the embargo with them, I don't believe it's something you'd do with multiple Journals. If I'm right about that, I may also be right about the Journal waiting for something that's out of the company's or the clinicians hands, like something official from the FDA. I'm not saying this is the case, and DI certainly didn't say that either, but he didn't deny the possibility.
I frankly forget which poster asked what they've done in the last two years, as though they've done nothing. I believe that in the last two years the biggest thing they've worked on has been gaining acceptance of the FlaskWorks unit, a key to commercial use of the vaccine. They're also preparing submissions for all the regulators, but again the key is having the manufacturing capability, i.e. the FlaskWorks approval.
No company I'm familiar with has given a report indicating we're 70% or 80% or 90% etc. of the way toward completing a BLA, etc. They may say it's being worked on, perhaps even specify what quarter they're targeting for submission, but most companies don't even go that far. In most cases you learn when something's been done after it's done.
I have no doubt that a great deal has been done in the last two years, but it's work in progress, not completed. The fact that a regulator will be inspecting our production facility and hopefully approving it for commercial use is a huge step, even if the regulator asks for some minor changes prior to approval. In other companies I've seen our FDA delay approvals for well over a year because they wouldn't approve the manufacturing facility. A product cannot be approved until its production facility is.
I think that all who believe the U.K. will be first to approve are right, but I have no idea if the others will be a few months to over a year later. I suspect it will be at least a few months. When the U.K. accepts the production facility I suspect that the others won't be that far behind, with the possible exception of our FDA who has frequently balked at facilities accepted by others. If the FDA insists on additional changes they'll cause further delays, but probably just for U.S. approval.
Have no doubt, adoption of the FlaskWorks units to manufacture the vaccine is a huge game changer, without it you would have to build hundreds of thousands of clean rooms if our vaccines, or other personalized products, are determined to have benefits in many forms of cancer, and perhaps other diseases as well. I believe that with modifications our units may be adapted to many future products and FlaskWorks, by itself, could become a major profit center under NWBO for manufacturing products that NWBO has not developed at all. This is no doubt years away, but if NWBO remains independent it very well could happen.
We've all had our lives changed by Covid-19. Who knows, the day may come when the vaccines we take to prevent it, and perhaps flu's, cold's, etc. are all personalized by utilizing our blood, and a device like the FlaskWorks unit. It seems far fetched today, but in a decade or so no telling if your local pharmacy, or compounding pharmacy may have a similar unit and be capable of making certain personalized products.
I know I'm going overboard, and I won't be around to see it, but I believe that personalized products will be quite common by the middle of this century. The device that makes them might look nothing like the FlaskWorks unit today, but might still carry it's name and be associated with NWBO as the XX generation of the unit.
Gary
AI
