So if you look at NWBO/Flaskwork’s + FDA + NIH/NIAID as a triangle. They had two parallel motivations.
1. NIH/NIAID and FDA primarily wanted closed system cellular production to avoid contamination. 2. NWBO/Flaskworks primarily wanted automated dendritic cell generator to meet anticipated increased production demand and simultaneously lower production cost.
Of course, they each held the other objectives above critically important as well. For instance, the NIH hoped it would make dendritic cell studies easier to conduct.
LP taught manufacturing and commercialization at NIH.
In June 2015, approximately one month before the screening halt in DCVax-l trial, NIH was temporarily suspended by the FDA from manufacturing Albumin, due to uncharacteristic lassez fair attention to sanitary conditions in producing and storing albumin (some isolated fungal contamination of albumin resulted). The NIH did not, however, supply the Albumin for DCVax-l.
Over the years. Doc Logic occasionally reminded us about the peculiar timing, and also pointed out the Germans also concerned about addressing biological production, and they concluded closed system production was needed (as some of us researched in due diligence from German patent documents. They even slowed some NWBO patent down on this matter, but eventually approved it.
Anyway, go back to December 10, 2014 (six months earlier) and an NIH professor on manufacturing and commercialization, was wearing her other hat, CEO of NWBO, and telling us that the only ultimate answer to meeting high demand was closed system automation.
By June 2015, you’d think NWBO investors would be told that NIH and NIAID were going to fund genius Shashi Murthy in that same month, to develop a closed system automated dendritic cell generator. Although the info was publicly announced, everyone here had no idea about the project that was anticipated to take four years, which it did, and was completed in 2019. The patent was granted in August 2020, and a few weeks later, we learned NWBO bought all of the NIH/NIAID funded work by Acquiring Flaskworks for a very reasonable sum.
In my opinion, NWBO knew about this project all along. They knew it would address production capacity to meet future anticipated demand whilst lowering manufacturing cost, and they knew it would meet regulator external need regarding manufacturing dendritic cells without threat of contamination. They also knew it would add another layer of IP and trade secret protection to the manufacturing process.
Why keep this parallel track hidden from investor view for five years?
It could be because the dendritic cell generator also provides another layer of patent protection in the DCVax-l manufacturing process, that now goes out to 2040. So they may not have wanted competitors to know NWBO was going to swoop in after Flaskwork obtained their patent. It could be they possibly did not want investors in June 2015 to know this dendritic cell generator project was expected to complete in June 2019 (Aug 2020 to get a patent grant), because that would then put a whole different angle on the six year and counting wait since the enrollment completion/halt.
Why do we think the regulators are supportive? This was a regulator funded project that was one way to address another regulators concerns about safe biological manufacturing.
Wonder why we haven’t yet been wrist slapped on clinical trials.gov? You might have a NIH professor, the NIH, NIAID and indirectly the FDA’s appreciation to thank for that.
Do I think investors should have been apprised of this possible scenario back in 2015? Yes, but it’s water under the bridge. I’m not gonna go there. For various reasons.
LP stated in December 2014, they were thinking a “lot” about how to meet unimaginable demand for DCVax-l. Her conclusion? Closed system automation was the only answer.
