Agree it would be great to hear more clarity about
Post# of 154089
(Total Views: 579)
Posted On: 03/24/2021 4:02:01 PM
Agree it would be great to hear more clarity about RO testing for the BLA, since this is so important to bringing in revenue possibly this year.
I heard on the CC them say there were two problems from RTF: (1) justification for dosing section, and (2) something about the RO testing.
We don't even know what dosing we are requesting for the BLA: 350, 525, and 700 mg all? I think FDA discouraged the 350 mg dosing. Maybe FDA wants to see how RO levels change with the different dosages. Maybe CYDY did different RO tests for each dose (different vendors with different methods), and have to come up with the same test (FDA approved) to be done on all samples from all the HIV trials done at different doses?
I think what is different now is that they have two vendors working on RO testing on HIV samples, which FDA told CYDY they wanted done a certain way. I think it took some time to find the vendors to do it, and to do some test runs, then contracts, payment for the work, logistics of getting the blood samples, etc...
Who knows?
Hopefully the re-write of the dose justification section flies with FDA, and it's not too much trouble to get the new? RO testing FDA requires.
4 more months seems like a long time for RO testing, given the RTF was so long ago. Why is it so difficult? Inquiring minds want to know. Doesn't make much sense why FDA couldn't approve HIV combo at 350 mg, but what is CYDY supposed to do when given the hoops to jump through? Keep jumping.
I heard on the CC them say there were two problems from RTF: (1) justification for dosing section, and (2) something about the RO testing.
We don't even know what dosing we are requesting for the BLA: 350, 525, and 700 mg all? I think FDA discouraged the 350 mg dosing. Maybe FDA wants to see how RO levels change with the different dosages. Maybe CYDY did different RO tests for each dose (different vendors with different methods), and have to come up with the same test (FDA approved) to be done on all samples from all the HIV trials done at different doses?
I think what is different now is that they have two vendors working on RO testing on HIV samples, which FDA told CYDY they wanted done a certain way. I think it took some time to find the vendors to do it, and to do some test runs, then contracts, payment for the work, logistics of getting the blood samples, etc...
Who knows?
Hopefully the re-write of the dose justification section flies with FDA, and it's not too much trouble to get the new? RO testing FDA requires.
4 more months seems like a long time for RO testing, given the RTF was so long ago. Why is it so difficult? Inquiring minds want to know. Doesn't make much sense why FDA couldn't approve HIV combo at 350 mg, but what is CYDY supposed to do when given the hoops to jump through? Keep jumping.
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