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Sunday, May 02, 2021 10:53:05 AM
It is the most important what is happening with our drug and our company now ,
And why we don’t have full approval in combo by now , and no EUA in covid .,
As patients dying daily in both diseases .
— FDA did everything not to approve HIV combo , even that study finished in February of 2018 with 81% efficacy ,
But since then FDA asking for a different things for BLA every few months ..
Last request was October 2020 when for the first time after study finished in February 2018 they asked for Occupancy Receptor Test , this test was never asked for when study was ongoing . So it was never done ..of course ..
And since we be using 700 mg only , what is a reason for this test , no doctor will ever order this test , no tests which are not helpful in treatment are ever order ..
So what FDA really want here ???
What the real reasons here ???
— why when dr Lalezari asked for 4 weeks treatment for CD12 patients , FDA refused and gave us protocol for 2 weeks .
And now to compare to other drug doing study for covid ..
Lenzilumab , FDA approved quietly the same protocol as for Remdesivir , but different that approving for other drugs .,
Protocol
when management could “ PICK” , as CEO of HGEN said , during ongoing study , and change primary endpoint few times to accommodate results of on going study .,
Why we talking about 100 doll 30 years ago , and not this obvious , at least not ethical things going on with NIH and FDA.,
No management will win with this conspiracy .,
All imo
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