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TheRedBaron888

01/07/14 2:14 PM

#3237 RE: longusa #3236

long, I would like to think that is NWBO's gameplan. And that potential to expand the platform rapidly is what attracted me to the company (apart from demonstrated efficacy, with an excellent safety profile), first in 2008. Would love to see what you said play out.

Flipper, I don't think management has bandwidth for DCVax-Prostate right now. Also, any potential partners may want to wait for early DCVax-Direct results to gauge the efficacy of the improved DCVax platform in general. Also, I wonder if there aren't efforts on in the background to try and subsume the DCVax-Prostate technology into a more generic DCVax platform (perhaps with a tweak for prostate cancer i.e. loading prostate specific membrane antigens ?). The following is from Dr. Marnix Bosch's presentation at the Brain Tumor Biotech Summit on 07-Jun-2013. The slide was on the potential indications for which DCVax-Direct can be applicable. Note the mention of prostate cancer...

Potential indications: all non-resectable (inoperable)
solid tumors, such as:
o Liver cancer
o Liver metastases of colon cancer
o Head and neck cancer
o Esophageal cancer
o Prostate cancer
o Other cancers
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flipper44

01/07/14 2:57 PM

#3240 RE: longusa #3236

Long,

The NDA filing for 2nd generation DCVax-L under your proposed timeline is why I think our congress needs to look at updating their stem cell and immunotherapy dendritic cell (autologous) approval legislation. Japan has done this, and the procedure you propose -- including a mandatory post market confirmation study -- would be allowed. IMHO. If things go well for the current versions of DCVax-L and Direct, I hope NWBO does not have to go to Japan first to get early approval for 2nd generation L.