Cytodyn Inc (CYDY)

[misiu143]

StealthGold,..
" We did not have dose justification from HIV. That is not correct at all "

Yes we have dose justification in HIV , above statement is not correct at all !!!

We finished HIV combo study February 2018 with 350 mg.
FDA asked us then to do study with 525 and 700 mg and give them the results..
And that's what company needed to do ,
study with 100 patients on 525 , and 100 patients with 700 mg , and study were for 24 weeks as our combo phase 3 with 350 mg .

That's was dose stratification for HIV is ..

" Once you understand that you then can understand that the only ways CYDY could justify 4-doses to the FDA is either by providing the HIV safety and efficacy data to the FDA , or doing dose escalation study "

Yes , one should know and understand well what really happened and then comment..

Company provided to FDA both , the safety and dose justification in both HIV and cancer , there was no need to do it for 2 years now in covid during this pandemic , when people needlessly dying every day.....
When study in HIV was finished with 350 , 525 and 700 mg , all this was given to FDA by their request, They evaluated our efficacy and safety and gave us advice to ask for 700 mg in our BLA ..

So FDA knew and evaluated all the results of HIV studies , and after that they picked the best dose.
What Amarex didn't do , and it is done now is aggregated safety data , but this is different.

And Dr NP didn't want to waste 2 more years during pandemic , and do study justification for COVID , Very correct imo.

And dose justification has nothing to do with how many doses to give to patients ..and Dr Patterson asked FDA for 4 doses base on how high Rantes were at 14 days in severe/critical patients , and Dr Harish and Dr Otto Yong and Fr Lalezari asked FDA based on their treatment of EIND patients.
All of them explained to FDA that for severe/critical patients to give 2 shots , at 0 and 7 days only is not enough.
And why DSMC doing interim didnt recognize a problem , not enough of doses of drug.
First class student could recognize this , and they said.." don't change anything , just continue "
Why was that ??? ..Dr Lalezari asked specifically ..
" are 2 doses enough ?"

There was not one honest reason for FDA to refuse 4 treatments in severe/critical patients in our CD12 ..

All imo.

Below interesting article, new observation of bone loss with COVID..

" Coronavirus infection can lead to SEVERE bone loss in arms , legs and spine , leading to weakness and abnormal fractures "

All this is due to severe inflammatory process in bone , so we know that leronlimab could prevent , cure or at least help a lot in this condition..

https://apple.news/A9I7FlwT5Rg2ruNSe58hZbw

GLTA longs.