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Posted On: 10/27/2021 7:25:36 PM
Post# of 148924
Re: generactor #108802
generactor,
I think it's important to take things in context. For me today's revelations must be considered in the contemporary context of early 2020.
All throughout 2019, I was hoping that our approval would happen. Not just BLA. I was more green then, but in each CC we got word that it was coming soon - at least the BLA and eventual PDUFA date.
So by the fourth quarter of 2019, timelines were being given, and submission by EOY was imminent. This is why I was bummed to have to miss the Dec '19 conference call while on an International flight. I think the Vyera deal was announced on that call, my first hearing of MS...but no HIV.
After this call was when I made the majority of my purchases of CYDY.
__________________________________
I set this table, because the email in question was a matter of weeks later when expectations were heightened, Amarex was already becoming a problem behind the scene, I believe we had rolling review, and Nader diplomatically asked for something to get done concerning the rolling review HIV BLA because the peanut gallery was getting louder.
Me, you, and the sign post outside of the FDA know how loud the peanut gallery can become.
These are some of the things Nader was dealing with in the Spring of 2020. In contemporary context, I don't have a problem with his email.. I have a problem with it being ripped out of context to stand alone.
Good Luck,
Chazzle
I think it's important to take things in context. For me today's revelations must be considered in the contemporary context of early 2020.
All throughout 2019, I was hoping that our approval would happen. Not just BLA. I was more green then, but in each CC we got word that it was coming soon - at least the BLA and eventual PDUFA date.
So by the fourth quarter of 2019, timelines were being given, and submission by EOY was imminent. This is why I was bummed to have to miss the Dec '19 conference call while on an International flight. I think the Vyera deal was announced on that call, my first hearing of MS...but no HIV.
After this call was when I made the majority of my purchases of CYDY.
__________________________________
I set this table, because the email in question was a matter of weeks later when expectations were heightened, Amarex was already becoming a problem behind the scene, I believe we had rolling review, and Nader diplomatically asked for something to get done concerning the rolling review HIV BLA because the peanut gallery was getting louder.
Me, you, and the sign post outside of the FDA know how loud the peanut gallery can become.
These are some of the things Nader was dealing with in the Spring of 2020. In contemporary context, I don't have a problem with his email.. I have a problem with it being ripped out of context to stand alone.
Good Luck,
Chazzle
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