NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

norisknorewards,

The 17 missing SOC/placebo patients have always represented a guaranteed approval to me. Regulators don’t run interference (lowered powering by keeping out 17 SOC/placebo patients) in a trial without good reason (Fraunhofer stated the trial was enrolled to the point statistically necessary) and without a pathway forward for a trial that has proven itself effective. That pathway forward, I believe, has always been predicated upon being able to manufacture L at commercial scale rates to meet demand. Well that was going to run into a problem if L was to become SOC for both GBM, rGBM and sought after for off label use privately and in clinical trials as well.
Then Covid came and changed everything to where I believe the hope was to get Edens ready by the time the BLA/MAA would be ready because of delays and waiting on ECA guidance to be written in stone which seems to have been required for JAMA Oncology not to front run regulators. Then talk about tissue agnostic designation and proof of it likely sealed the deal. This is obviously a platform tech due to the very nature of DCs and really all NWBO needs to do to prove this is demonstrate that proper activation and maturation is all that is needed. They did this with proteomics to prove they have the secret sauce. So bottom line is NWBO has been working on creating the runway with government clearances granted or created along the way. That is what the missing 17 SOC/placebo patients (from Germany) means in my opinion which is why NWBO can’t comment on it and barely says more than absolutely necessary. Best wishes.