NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

We are going round and round. Let me try something else. John published Doctor Gorter's work on Ihub with dendritic therapy. Gorter lives in Germany. Germany looked under the hood at every nut and bolt of the DCVAX-l manufacturing process in Tennessee (as well as the DCVAX-Direct program). Germany looked at every piece of info they could get their hands on in England and Israel. Germany probably talked to Doctor Liau and Doctor Triozzi. Germany has incredibly smart people in the PEI and the Fraunhofer Instititute who probably collaborate with nearby King's college in England. 3 (some say 2) phase I/2 trials with 39 patient records are available to look at that used DCVAX-L. They looked at Dr. Liau's review of all dendritic work in her 2010 pubmed comprehensive review of almost all the trials performed on GBM with dendritic therapy. They looked at Wheeler's studies and reviews. They looked at Gorter's work within their own country. They examined something like 80(?) patents. They probably looked at NWbio's books. They have a very robust sharing agreement with the FDA to further medical advancement and safety. The DMC allots for ongoing trial information sharing with special privacy guidelines in order to allow companies to pursue licensing agreements. The DMC has very special provisions to allow contact between themselves and the FDA.

Now, take a step back. These rules toward confidentiality and so forth are to guard against "the placebo effect." Guess what? We have math majors on this board, current and former CEOs, Med Students, very experienced investors in biotech, etc. Not one of them can tell you, with any sense of certainty at all, what Germany made their decision based upon.

Now, if you add early phase 3 interim trial data on the primary group in the above list I just gave you, Germany would likely have gone forward with the hospital exemption and reimbursement regardless if the data did not show statistical significance yet. Moreover, neither the DMC nor the PEI likely had access to the pseudo progression group analysis because that group's minimal event number had not been hit yet.

Now ask yourself? Do you think there is one patient in the phase 3 trial has an inkling from the German decision whether they are getting the placebo or not. I'll answer that. No.

Throughout history, science has always been a paradox. It is at once messy and elegant. This is especially true in biology. The dendritic cell probably makes the Roche's and Pfizer's of this world cringe. Why? Because those large pharmaceutical companies where getting very adept at building molecules, encoding genes, and generally starting to make science look like all we need to do is build the right answer. Then along comes this amazing dendritic cell that runs circles around medical science and makes everyone question why on earth they can't do what the Dendritic cell can do.

This is a long winded explanation to state that the process of licensing hospitals in Germany to treat GBM patients with DCVAX-L and reimburse the hospitals for doing so is done to save lives and the scientific process. Science, trials and treatment are not simply mathematical equations; they represent living and dying human beings and the adult balance which must be struck to coordinate several different priorities at the same time. If it sometime seems that your vision gets blurry, welcome to biotechnology.