NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Well, well well, Beartrap, maybe this video might be part of what you remember, I've just found one little gem. In this 2014 VIDEO, at approximately 6:15 minutes into the video, LP talks about what the fourth requirement is for the early access to medicines program in the UK. Basically once you have received the PIMS designation (which they had), you must then prove each of those elements again, plus the ability to manufacture the product consistently to very rigorous GMP standards for the UK's MHRA. LP talks about their then prior ten year work to be able to prove this fourth criterion in the second step of the EAMS process when she spoke back in 2014 September. So soak that in. They had to get their manufacturing consistency top notch for GB and Germany. It's another clue they were still "honing" their manufacturing process up to that point. Even to improve it enough that each patient receives the same level of consistent product could mean improvements in survival. What were these improvements? Do the two patent grants in 2013 provide more manufacturing consistency? IMO, certainly they would. Cell potency is a necessary factor, and if you can more easily meet the required minimum potency levels after incorporating one or both of the patents, you have "honed" your manufacturing process to meet regulator expectations.

Remember, as Doc and even myself have pointed out, patients in the second half of the trial were sicker on average when they entered the trial before they started receiving DCVax-L. Yet, as Senti's count seems to show, the newer patients seemed to do better over time -- not worse.

1st 38 -- phase II before converted to phase III, only one to maybe three of these patients lived beyond 36 months (more likely one). (If count correct) (Researchers didn't have to address this imho, because they could write it off to not knowing the distribution of MGMT)

Next 149 seemed to have much better 36 month survival.

The remaining 149 patients seem projected, by extrapolating the count, to manage even better 36 month survival stats than that.

Review: Two patent grants in 2013 that can improve the opportunity to make more consistent product, imo.

Germany started manufacturing for UK in 2013, and for themselves a year later in 2014. All before LP spoke about their ten year honing of the manufacturing process.