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misiu143

05/02/21 10:53 AM

#162968 RE: Scooter McCabe #162963

It is really not very important that person have some problems with 100 doll 20 years ago or difficult divorce ..

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

djjazzyjeff

05/02/21 1:52 PM

#162997 RE: Scooter McCabe #162963

All one needs to do is ask themselves why a man with no biotech experience decides to suddenly buy an abandoned drug. He has no interest in biotech in fact any questions about trial details he can't answer and gets annoyed at. People say he saw the potential in the drug but how? The man admitted he didn't even know what biotech was when he bought it. Did he simply see an easy way to make money without producing anything? Well ten years and millions of dollars in outsized salaries and ridiculous bonuses with not a single approval later should answer that question sufficiently.