Tuesday, August 30, 2016 5:01:15 PM
You do realize that all prior work on any treatment can be classified as "IND enabling studies" don't you?
This has been the corporate line since inception.
And the reason Herpecide is further along is because they took Flucide OUT OF TOX at BASi. BASi was "apparently" (to use your term) waiting for more material to complete the large animal testing and then they would have been completed...but lo and behold, NNVC pulled out. Not only that but hit reset on Flucide altogether by saying they will be altering the "formula" thereby rendering all previous Tox work inadmissible for formal Tox. (and yes, they can include the existing small animal BASi Tox results as an appendix in the new Flucide Tox submission to the FDA, should they ever actually do one, which I have steadfastly maintained they will never do).
I wonder why?
Does anyone really think it was faster and easier to completely restart Herpecide, including selecting a new fully optimized candidate, commissioning the university studies, then manufacturing and conducting a new INDA meeting with the FDA to get the Tox panel requirements (and yes, that will be necessary even if they go to Australia for the clinicals), than simply giving BASi more material to finish what they had apparently gotten pretty far into Tox testing?
Recent NNVC News
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- Form 8-K - Current report • Edgar (US Regulatory) • 09/01/2023 08:46:45 PM
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