NanoViricides Inc. (NNVC)

[changes_iv]

“By 2011, when Dr. Diwan went all out and bought the Controls Drive property, we had spent several years searching for a third party contract manufacturer, capable of producing our drug candidates under the rigorous standards required for clinical trials, without success,” said Eugene Seymour, MD, MPH, adding, “NanoViricides continued to search for available contract manufacturing capability even after Diwan’s purchase of the Controls Drive property. Most facilities we interviewed could not manufacture our novel polymer molecules without extensive renovations. The cost of such custom renovations and equipment would be passed on to us, as is customary. In addition, we would have to train their technicians and scientists and transfer important know how and other aspects of our intellectual property.”

source: http://www.businesswire.com/news/rxtimes/20140220005581/en/NanoViricides-Reports-Evaluating-Purchase-Facility-cGMP-Pilot

It takes years because it is transformational, breakthrough technology. No Big Pharma or other "loaded mule" toxic-compound making operation had the capabilities of producing our small company low toxicity and safe drug candidates, under the rigorous standards required for clinical trials.

The Company has already successfully scaled up the synthesis to multi-gram scale, sufficient for animal testing, and can easily scale the processes to make kilogram quantities for widespread application in human patients if they are found to be effective and safe.

source: http://www.nanoviricides.com/press%20releases/2014/NanoViricides%20Reports%20Novel%20Drug%20Candidates%20for%20Treatment%20of%20the%20MERS%20Middle%20East%20Respiratory%20Syndrome%20Corona%20Virus%20Ready%20For%20Animal%20Testing.html

We now have the capability to produce the FluCide candidate in sub-kg scale as well as kilogram scale! Oh, wow! Seems to me they are already testing our new state-of-the-art drug designing software/computers, interfacing instruments and nanoviricide producing equipment in our new GMP Pilot Plant in Shelton, CT. We are going to hit the road running!!!

And how about the GLP Toxicology and Safety Studies at BASi Indiana? Scale up is done!!!

How fast could this GLP tox and safety studies go?

Why You Should Consider Automated In Vivo Sampling Systems - Automating Sampling

In automated systems, the animals wear harnesses that secure sampling, drug delivery catheters, and data-generating devices. For example, in BASi’s Culex Automated In Vivo Sampling System, the harnesses are connected to sensors that track the animal’s movements. These drive motors that rotate the floor to counter the animal’s movement, allowing the animals to move freely without tangling the lines. Because of this rotational movement, the Culex small animal system is sometimes (affectionately) referred to as the “Raturn,” and the large animal version the “Pigturn.”

“The animals recover quickly from surgery to implant the catheters, and the behavior of the animals connected to the Culex system seems the same as ‘normal’ animals. They just don’t seem aware of anything unusual,” says David Hopper, director of toxicology at BASi.

The key advantage of the automated systems is that they reduce the stress, as technicians do not need to handle animals to take any samples, and even the best socialized and trained animals will become stressed with repeated sampling. “Stress can make major differences to results of trials,” says Robyn McCain, manager and biopharmaceutics technician at Purdue Translational Pharmacology Facility, Purdue University. “We have assessed this by administering the same compound via an automated system with a gastric catheter vs. traditional oral gavage [introduction of material into the stomach by a tube] in rodents. We looked at the differences in drug absorption using blood samples. The plasma levels showed a difference in the rate of absorption, and we theorize this is due to the blood supply to the gut becoming altered because of the ‘fight-or-flight’ response during oral gavage. This could have had a major impact on the outcome of an oral metabolism study.”

source: http://www.pharmaceuticalonline.com/doc/why-you-should-consider-automated-in-vivo-0001

Fast coming our way...!!! Ignition sequence start...!!!