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Posted On: 01/21/2021 4:25:32 PM
Post# of 148903
Thanks, now we need a Nader interpreter to know what that means!
(1) FDA may have asked for combo RO data since it was also in mono trial, and FDA wanted to compare, but we didn't have any RO data for combo since FDA screwed us and only asked for mono data and combo RO data late in the combo HIV development process. So we went to FDA and filed without any combo HIV RO data, and hoped FDA would accept it later during review. FDA balked at this, i.e. "our RO test was rejected by FDA" means they rejected the idea of submitting RO data later, thus the RTF. This fits best with CYDY not having any combo RO data "if you don't have that [RO] how are you going to be able to .. file the BLA?" and BP saying they didn't do any RO for combo HIV trial. Now CYDY has two companies working to quickly do RO testing, and neither of them is InCellDx. InCellDx bridge probably burned when they filed a patent for LL treatment of Covid.
or
(2) "our RO test was rejected by FDA" means that InCellDx was doing all the RO testing, but FDA rejected it, or that InCellDx or someone else proposed of doing the RO a certain way, but FDA rejected those assays.
I don't think the second interpretation is correct, but the first.
FDA seems to have asked for lots of things after we already had everything we thought they wanted in hand for combo HIV indication. Now we are scrambling to get it. Has nothing to do with InCellDx doing any RO testing for us.
I think the interview that NP gave talking about RO (where BP couldn't provide an assay) was referring to RO for cancer, or maybe even instead NP probably meant an assay showing CCR5 in cancer tissue - I would guess it wasn't ready in time, so CYDY went with someone else? It's possible this all happened after InCellDx tried to file a patent on CYDY's drug for Covid application.
(1) FDA may have asked for combo RO data since it was also in mono trial, and FDA wanted to compare, but we didn't have any RO data for combo since FDA screwed us and only asked for mono data and combo RO data late in the combo HIV development process. So we went to FDA and filed without any combo HIV RO data, and hoped FDA would accept it later during review. FDA balked at this, i.e. "our RO test was rejected by FDA" means they rejected the idea of submitting RO data later, thus the RTF. This fits best with CYDY not having any combo RO data "if you don't have that [RO] how are you going to be able to .. file the BLA?" and BP saying they didn't do any RO for combo HIV trial. Now CYDY has two companies working to quickly do RO testing, and neither of them is InCellDx. InCellDx bridge probably burned when they filed a patent for LL treatment of Covid.
or
(2) "our RO test was rejected by FDA" means that InCellDx was doing all the RO testing, but FDA rejected it, or that InCellDx or someone else proposed of doing the RO a certain way, but FDA rejected those assays.
I don't think the second interpretation is correct, but the first.
FDA seems to have asked for lots of things after we already had everything we thought they wanted in hand for combo HIV indication. Now we are scrambling to get it. Has nothing to do with InCellDx doing any RO testing for us.
I think the interview that NP gave talking about RO (where BP couldn't provide an assay) was referring to RO for cancer, or maybe even instead NP probably meant an assay showing CCR5 in cancer tissue - I would guess it wasn't ready in time, so CYDY went with someone else? It's possible this all happened after InCellDx tried to file a patent on CYDY's drug for Covid application.
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