Wednesday, September 25, 2013 7:23:02 AM
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).
Recent NNVC News
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 10/15/2024 08:44:44 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 09/27/2024 08:15:38 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/09/2024 08:30:39 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 08/09/2024 08:05:25 PM
- NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • InvestorsHub NewsWire • 05/02/2024 02:07:42 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/16/2024 09:53:32 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 02/14/2024 09:55:35 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/19/2024 09:44:48 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 12/04/2023 09:08:49 PM
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