"Thanks for the reply. I do appreciate your point of view and have considered the evidence you and others have pointed to and the obvious lack of clarity given by the company. I do also know about the grant income which was set aside for trial participants. The HE reimbursement issue is separate from that based on the conditions given for its use. You should be aware of that if you are not." Doc Logic
The grant money isn't set aside for the trial participants specifically. Instead it is set aside to reimburse NWBO for the cost of manufacturing (getting manufacturing ready and the cost of vaccine production for the trial participants which may not include the HE program participant's vaccine production. But the manufacturing site will be used for both the trial and HE patients, but I would agree with you that most likely the German HE program is separate from the German Grant and that program has its major issues of ever being realized in terms of getting reimbursements ever negotiated successfully (IMO based on reading the ridiculous hurdles placed for those negotiations). Also, the SEC docs show that NWBO appears to be recognizing revenue way BEFORE they even treat their first German patient and even before they start "receiving" reimbursement from the German Grant- all kosher with accrual accting according to GAAP. There are other interesting stuff related to those reimbursements but that would be too much for this post.
"Bethesda, Maryland, May 1, 2012 – Northwest Biotherapeutics, Inc. (OTC Bulletin Board: NWBO) (NW Bio) today announced that, working together with the Fraunhofer Institute (IZI), it has received approval of a major grant from the Sächsische Aufbau Bank (SAB or Saxony Development Bank) in Germany. The grant will reimburse fifty percent (50%) of the costs for manufacturing in Germany and for NW Bio’s clinical trial with DCVax®-L for brain cancer at up to 30 clinical sites in Germany. The amount of the grant will be €4.15 million (~$5.5 million)."
Concerning CXCR4, still unproven how effective and useful it will be in a clinical setting, and IMO will only show potential in a combo trial with some other therapeutic therapy like a cancer vaccine or checkpoint inhibitor. As a mono-therapy, again IMO it would be too costly to use since it's MOA doesn't necessarily "cure" cancer but seems useful for maintenance therapy (I guess it depends on the cost of manufacturing for the receptor peptide inhibitors and how effective it is for maintenance therapy measured by durable responses for SD or prolonged PFS/OS. As I stated before MANY times, it will be costly to look at those endpoints, and for most cancer therapies, the fastest route is to look for durable ORR results which is why I'm so negative on Direct and am not surprised that it is taking so long to design the second part of that pI/II Direct trial. JMHO and best wishes to you as well.
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