What's funny is that the paper he quoted, which I read as soon as the HE for DCVax-L came out, has as its whole basis comparing effectiveness of therapies granted HE in one indication from different reg authorities (the EU licensed one included), showing that although they are all effective, the licensed therapy exceeds them, and so asks, is it truly in the patient's best interest for regulatory bodies under one centralized authority (EU)--such as PEI, MHRA, etc.--to have varying therapies for one indication of varying effectiveness? The answer is "maybe" (I find the argument spurious on certain fronts, but that doesn't matter). Somehow, the most important thing from that paper posted by him was that proving effectiveness in a clinical setting (an arduous, expensive, lengthy process) isn't a requirement for granting HE. That is a simple baseline understanding, and each reg body has their own requirements on top of that omission of necessity. However, most require at least Ph II clinical data for veracity (I'll let him look that up).
Note that they have "17 products which are legally on the market [and] are all hospital exemptions."
Also, "in Germany for hospital exemptions an authorization of the product by the higher federal authority is necessary."
If you want to compare HE granted by the PEI with something here, it is most like a cross between Expanded Access and Accelerated Approval (the latter without marketing approval).
If you study treatments granted HE, you will find most of them were already established and in practical use before the EU issued the memorandum. They are waived the necessity to show clinical effectiveness, not effectiveness at all (which would be absurd, wouldn't you agree?).
There is no doubt in my mind this is a massive validation for NWBO's DCVax-L. A simple glance at this emerging tech (DC vacc utilizing whole tumor lysate) coming from various sectors that NWBO is pioneering and which is well understood by the PEI and others, as well as stat sig efficacy data from NWBO's Ph I/II GBM, prostate and ovarian trials alone is enough for HE. But I'm also of the opinion (OPINION) that according to the FDA-PEI agreement, data from their ongoing Ph III was submitted to PEI also. No proof of this, other than a very coincidental timing, and what I understand of what happens when a company is granted fast track designation (which can be sought and acquired at "any point in the drug development process"). FDA is unblinded to all data at that juncture, and according to their agreement, FDA commits to sharing, among other things, "non-public, pre-decisional information" with PEI.
I also have no doubt, that like PEI's other 17 licensed HE therapies, DCVax-L will be not advertised via the gross methods employed by drug makers here, but by every medical professional privy to the therapy that are in the position to treat GBM in Germany, and that would be all of them. 7,000 patients per year in Germany alone is an easily attainable patient pop for treatment with DCVax, and yes that means substantial reimbursement to NWBO. On we go...
Btw, how many therapies have ever received HE to date? And DCVax-L could have been given only one year, but was granted five. But I guess all of that is no big deal...
My advice to you my friend is to do your own DD, and be wary of anything you read on a message board--including this.
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