Replies to post #802934 on NorthWest Biotherapeutics Inc (NWBO)

[Survivor2012]

Hello theorysuit, The FDA directed NWBO to change the primary endpoint from Progression Free Survival (a statistical extrapolation) to Overall Survival (The gold standard for survival, i.e., patients are actually still alive). They did this because of psuedoprogression, a major issue in immunotherapy trials. It is too difficult to distinguish true progression from psuedoprogression, because in psuedoprogession, immune cells infiltrate the tumor site (on scans, it appears that the tumor is growing, but it's not). So psuedoprogreesion (as the word implies) is not "progression" at all, it is proof that the treatment (e.g., DCVax-L) is actually working. And even more "proof," is the fact that the this Phase III trial "proved" (with "p" value of .0002 -- statistical significance) that the 5-year survival for GBM patients treated with DCVax-L saw a 250% improvement over standard of care (chemo and radiation) for surviving 5 years (13.2% v. 5.7% survived for at least 5-years). And we know that many are living much longer than 5 years (per Dr Linda Liau--you are familiar with her credentials, right?). I could go on and on by talking about (in detail), the Nature.com article, Hiltonol, Keytruda, Compassionate use, why DCVax is tumor agnostic (pretty much common sense when you understand the "mechanism" of (DCVax-L) combining tumor (yes, any tumor) lysate with dendritic cells and creating a personalized vaccine that is administered like a flu shot--did I mention it has no side effects? And, we know what we know (don't we), that NWBO has met every milestone as far back as getting SAP approved and in no particular order, Phases I, II and III trials completed at 89 sites, in 3 countries for 331 patients, Data Lock, Top-Line data released with stat-sig results, Jama article published, manufacturing certified, PIP approved, MAA submitted. Oh, forgot the Roswell in-license; ooops, forgot to mention Flaskworks and Advent purchases and now rapid expansion of manufacturing capabilities in U.K. and U.S. Shall I go on? And of course, certain groups of non-invested posters on this board said none of these milestones and/or achievements would ever happen or be reached. So, now we have (imminent) MAA approval -- oh, but we know what you are saying, "it will never happen" -- sound familiar!!??

[HyGro]

NWBO was desperate as they certainly don't have the time or money to do another decade of P3 trial again. Whe FDA said don't bother filing with them, they looked for the best option and with Advent in UK and EU a tougher reviewer, they went UK. But even that required years of review likely with several RFI's to answer questions about trial design. It's make or break for NWBO -- it they fail they'll become a contract manufacturing company.