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09/08/19 7:02 PM

#243219 RE: HappyLibrarian #243193

Here's what I think... I think that before the "discussions" started taking place between Cognate and NWBO regarding that $500k monthly fee, Direct could have been accessed, however not easily. Then when that discussion began - I think they began sometime in 2017 but I'm not sure, the SEC filings would indicate exactly when - I think access to both L and Direct became a lot more difficult because I don't think Cognate was fired up and ready to go anymore. In fact, they may not have been fired up and ready to go for awhile before the discussions, which could have precipitated the start of the discussions.

Now... once that $1m was paid to Cognate - after the Sawston sale - for which part of that was to pay to turn on the Cognate Kilns for the Direct trial at Mayo - then yes, I suppose it's possible that Direct was available through some means that I'm completely unaware of. I think, though, not.

Is it possible that your friend is thinking of some other dendritic cell vaccine that he had a choice of, from another source, and that he's mixing it up in your discussion with him, thinking it's the same thing?

As for L being rendered obsolete... I'm not sure I see that happening.

There will be times when you'll want to remove the tumor first, in which case, I think L still is the-go-to treatment.

The thing is, Direct is, for sure, made with the TFF (Tangential Flow Filtration) system, and I think that process is part of what increases the potency of the dendritic cell vaccine, some think, ten-fold. I believe the company intends to upgrade the L manufacturing process using TFF as well. The question that has been batted back and forth over the years between myself, flipper, Doc, Lykiri, even RK, and a few others, is did they implement TFF at a later point in the P3 trial, or not. If not, then I think they intend to eventually do so, perhaps on the next L trial. I would think that would be the time to do so, but I could be wrong.

Anyhow, L manufactured with TFF strengthens L even more... at least that is the working hypothesis.

More about TFF.
https://nwbio.com/nw-bios-patent-portfolio-further-expanded-with-manufacturing-automation-patent/