Replies to post #800335 on NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

ASw,

Thanks for asking 😶

No, longs are not concerned with tin foil hat conspiracy theories…

The dendritic cell vaccine platforms at Roswell Park & UCLA have been supported substantially by U.S. federal funding. U.S. NIH 🇺🇸 & U.S. Department of Defense 🇺🇸 peer-reviewed grants have together provided tens of millions of dollars to advance DC platform technologies into clinical trials.

DCVax-L & GBM are no longer the only platform & indication awaiting submission for FDA review. The required automation technology is just now catching up, combos are in play & have reached PII, & we now have multiple platforms/combos that will be candidates for FDA review too. Ironically, slow developments have evolved rapidly in recent years!

Standardized automated manufacturing is the key to regulatory approval in multiple countries, especially for novel cell-based products like DC vaccines.

DCVax-L, DCVax-Direct, & the Roswell aDC1 platform are all pipeline candidates on clear clinical development pathways advancing toward 🇺🇸 U.S. FDA review.

[Investor082]

“It seems more and more clear that NWBO never intended to submit the DCVax-L trial results to the FDA”

— 1000%. FDA has pretty much indicated that the phase 3 data and ECA will not fly under the current regulations. Thats why Dr Musella has been trying to get the new pathway act passed. Again, NWBO has withheld this info from shareholders! Otherwise any serious company would have applied to the world’s biggest and most lucrative market in less than 5 years from data lock regardless of how big or small the company is (as long as the data is semi decent!).

Also, NWBO indicated earlier this year including the last report that they are looking at striking manufacturing contract in the US for their in-licensed Roswell tech rather than their own DCVAX-L. Tells you that DCVAX-L is not in their commercial plans for the US.

[Nemesis18]

It was impossible for NWBO to submit an application to FDA, for they knew >2years ago that their P3 trial was corrupted , preferring to attempt to slip in under the radar of the perceived 'back water' UK regulator !
Simply relying on the Regulator's ignorance of the science to carryout a fraudulent bait & switch. If the trial evidence spoke for itself, you would not have needed 1m+ pages of smoke & mirrors.
So it wasn't really about the certainty of UK approval, rather a means to PR yet another incentivising carrot to increase the next round of investors ( which has been repeated et nauseam over 20+ years of this scam.
You all have been had unfortunately.