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Thursday, July 18, 2013 8:31:24 AM
Two events that precede the coming series of parallel events beginning this year:
->BASi for Toxicology and Safety Studies - agreement signed Nov 12, 2012; NNVC ANTICIPATES that it will need very large quantities of the drug candidate for these “tox package” studies.
->NNVC announced it has retained the services of Mr. Phil Mader and his firm, MPH Engineering, LLC (“MPH”), to help with the overall project management and design engineering of its laboratory and cGMP pilot production facility
According to your 6 month modeling, if the cGMP facility is physically completed by or before Sep - Oct 2013, it will be sometime between October 2013 and April 2014 when they start production of the test batches.
Events running in parallel for a year - beginning sometime between Sep - Oct 2013 when cGMP facility is physically complete:
-cGMP plant/facilities complete sometime in or before October 2013; transition to full production of TEST BATCHES begins sometime before Apr 2014;
-Human trials begin outside the U.S. (Australia) sometime during first half of 2014. Since it is outside the U.S. no FDA approval is necessary
-Sometime close to/before April 2014 FDA certifies cGMP plant/facilities; production test batches have begun; test batches can be employed in Human trials Australia as well as for Tox studies.
Puffer, you've said, "As a near term catalyst you've got potential Dengue approval for orphan status both here and in Europe. That should be forthcoming, possibly within a few weeks (due within 3 mos of 10 Jun in the U.S.). Beyond that I would encourage people to look at the big picture. We could be in or very close to human trials 1 yr hence. Phase I/IIa should only take about 6 weeks... positive results there and $1.00 will be a distant memory. I would also expect higher prices as we approach those trials."
I must say I like the big picture. Nanopatent recently brought to our attention Nanowerk news -- Cancer nanotechnology: Nanoparticles with protein 'passports' evade immune system. Others have alluded to a similar mechanism/passport employed by NNVC in the "human-like cells" or nanomicelles.
Download the "soaring to new highs" video --
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