Yes, the fact remains that if phase I or any other human trials are to be done in the USA the FDA has to approve it. I stand by that statement. If they are done in Australia the FDA doesn't have to approve it, but given that NNVC isn't likely to be ready to do phase I testing until early 2015 I don't think it matters very much where they do the tests.
Sometime in 2014 (hopefully 1st quarter 2014 but maybe later) we should have the results of the tox testing. Sometime in 2014 the manufacturing facility should be working. I have no idea how long it will take to get the bugs out. Scaling up from tiny lab batches to production level batches of Flucide is bound to present problems. What I do know is that once production is working well there will be more months of "unexpected" delays before phase I begins, because there always are such delays. After all, how many people here thought, after NNVC had their pre-IND meeting with the FDA last year, that in May 2014 we would still be waiting for tox testing to start?
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