The point you appear to be overlooking is that Australia has different (and lighter) standards for pretoxicology studies. No one has maintained that they don't require any.
The way I interpret it is that NNVC could use early work on the toxicology studies for Australia while continuing to complete the rest for the USA FDA, thus still getting an earlier start in Australia. Depending on how that worked out with the flu seasons that could save up to six months IN ADDITION to the shorter time to get the tox studies to Australian standards.
There are a number of advantages in getting started earlier by doing it in Australia:
1) the clinical trial data would be coming in six months sooner, which will move the research forward that much faster (and speed up the US CTs because they can use data from the Aussie Phase I to begin planning the USA Phase II while the USA phase I has not yet even begun or even to modify the USA phase I
2)The data from the Aussie Phase I (if good) would greatly boost NNVC's credibility.
3) Eventually income would be coming in sooner as well. From a smaller market granted but the revenues milestone, a very major event for any company would come that much sooner.
The key concept is to use the early part of toxicology studies being done for the FDA for the Australian application. If something needs to be done differently for Australia they can do both at the same time (extra resources but NOT extra time).
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