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Monday, September 23, 2013 12:34:31 PM
“We are rapidly advancing towards our goal of filing an IND with the FDA for Influenza based on the guidance we received in our previous pre-IND meeting with the FDA,” said Anil R. Diwan, President of the Company.
As has been pointed out repeatedly here, Diwan and crew have at least one FDA workshop where they presented early findings and received feedback on what animal studies need to be performed. Also, through several NNVC associates--Barton and Fields are good examples of people who have contacts within the FDA--Diwan et al have been in regular contact. So, the assumption that these decisions to continue testing and the time to compile a submission are all done in a vacuum is simply not true. ~ BigKahuna
The Company (Nanoviricides, Inc.) anticipates that it will need very large quantities of the drug candidate for these "tox package" studies. The Company has found FluCide to be safe in animals at large dosages, and will need to determine certain safety and toxicology limit parameters. ~ Marketwatch.com
The Company believes that it has received valuable guidance from the US FDA in this meeting. We believe that the guidance we received goes beyond FDA guidance documents, and is more specific for our drug candidate, NV-INF-1. The Company will now plan and execute the studies identified based on this meeting. ~ Businesswire
I'm pretty sure that the MTA is already effective. The question now is how long will it take to develop an anti-MERS and ANTI-H7N9 viricide, and send the materials to start the testing? Has Diwan and crew already developed one or both? If not, how long might it take? 3 to 8 weeks? ~ BigKanuna
IMO, the biggest thing, Anil was able to develop the MERS solution in less than a week. Less than a week for the type that will be tested in EU is pretty amazing and beats the 3 weeks of the rapid in field technology they previously talked about. ~ BigKanuna
"...we are a company...with the ability to rapidly create drugs, and when I say rapidly create drugs I'm talking about weeks instead of years..." ~ Dr. Eugene Seymour, CEO Nanoviricides, Inc.
"by the way, I'm sure that when you think human trials for drugs you think of hundreds of millions of dollars and years of time, well in this case because the disease only lasts a week, two weeks,...that it is possible to complete human trials in the space of a few short months...four parts to the human trials" ~ Dr. Eugene Seymour, CEO Nanoviricides, Inc.
...important events can happen really fast with the "transformational-technology" of NanoViricides, Inc.
What do I think about Nanoviricides, Inc./BASi "tox studies"? They will start and move "fast and furiously" to their end, just in time to meet the projected Milestone -Receive initial results toxicology studies FluCide ~ 4Q 2013. More good news are coming our way!
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