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DaysOnTheBeach

07/17/14 4:32 PM

#94634 RE: daBoze #94631

Wow, that's really well expressed! Much better than what I wrote. I'll keep this handy for the next battle, thanks!

Best to all.
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Rawnoc

07/17/14 4:34 PM

#94635 RE: daBoze #94631

Nonsense. Contrary to popular false belief, the info was widely known YEARS ago and doesn't even remotely excuse 2014's missed deadlines over and over again with NNVC still not having a clue.

Unless NNVC can explain some new FDA test requirement that began in 2014, there are ZERO excuses nor blame for the FDA that explain why 2014 deadlines were missed badly.
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Ubertino

07/17/14 4:34 PM

#94636 RE: daBoze #94631

The FDA is hidebound by tradition and needs a boot in the arse to move them into the 21st century - the one that NanoViricides (NNVC) will dominate.
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JG36

07/17/14 4:37 PM

#94637 RE: daBoze #94631

NNVC is not responsible for the test requirements of the FDA. But NNVC certainly knew the test requirements, in detail, after their pre-IND meeting over two years ago. NNVC certainly knew how much Flucide they'd need after they did the initial tox study last year. But still we got the song and dance about how they'd scale up their existing lab to produce the Flucide for the tox so it wasn't dependent upon the new building.

The story keeps changing.

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TheBunny

07/17/14 6:05 PM

#94648 RE: daBoze #94631

OK, here we have it. The vast Big Pharma conspiracy is already skewing the requirements for Tox. OK...


Until the FDA revises its protocols to account for this new generation of drugs the development companies are stuck with it. Thus, NNVC will rely on the more sane requirements of administrations such as Australia.




Perhaps NNVC can get even more saner requirements than Australia from a Health Minister of Borneo or New Guinea, at a fraction of the U.S. cost.

Didn't we go through this exercise a few years ago ? What a Joke !