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Posted On: 10/31/2021 11:06:45 AM
Post# of 148903
aaron from ymb hits it out of the park
Aaron10 hours ago
Let's be clear the entire RTF is directed at one person.
Kazem Kazempour, CEO of Amarex!
The letter is professionally addressed to Kazem Kazempour specifically in the FDA opening address. His name is in the heading as well as the introduction.
Let's be clear, nowhere does the FDA reviewer mention NP nor anyone specific besides Mr. Kazempour! Everything the FDA reviewer states when addressing the "you" in this RTF is directed at Kazem Kazempour, CEO of Amarex.
I establish this distinction for a reason. This RTF is excoriating and the person being excoriated is the head of Amarex!
It says: "...as we told you in our December 16th, 2019 correspondence..."
This is in reference to the many deficiencies of the RTF and the reviewers frustration is that he guided Kazem Kazempour ("you"
months earlier as to what needed to be done and Kazempour didn't follow the instructions!
The FDA reviewer notes that the Date referenced above is the SECOND TIME they have discussed the subjects such that his time was being wasted "Despite the specific advice above, which echoed the advice we provided you on January 22, 2019...the BLA only includes a 2 page "rationale for dose section that is identical to the rationale (previously) provided... which we told you in our June correspondence is insufficient!"
Digest that last sentence. The FDA reviewer has actually corresponded directly with Amarex and specifically Mr. Kazempour in June of 2019, told him his work and submitted material from January was insufficient, then echoed that information in December and now is pointing out that Mr. Kazempour has simply submitted materially the same deficient information!!!
Take a look at page four here! Nothing circled. Read it all! It's Kazem Kazempour describing to the court in the current Amarex case what his qualifications are!
Thirty years experience with CRO and trial collection and he actually worked for the FDA as a senior staff member overseeing clinical trials!!!!!
And yet an FDA reviewer has to point out multiple times that he isn't doing what is required even after multiple meetings? What excuse could there possibly be for the head of a CRO with actual FDA inside experience to not understand the FDA reviewer request?
Amarex says Cytodyn owes them $14 million!
Remember, it's not Amarex that is suing for their money but Cytodyn that is filing arbitration. NP claims Cytodyn should not have to pay for work not performed.
And the first piece of evidence handed to the court? An FDA letter where an FDA reviewer says he has advised Amarex (CEO Kazempour) multiple times on what is required over a fourteen month period and Amarex didn't do the work!!!!
This is Amarex argument? It's NP fault that after fourteen months and multiple requests and correspondence from the FDA Amarex failed to do it?
Let's see how this works for the current lawsuit and the arbitration.
Oh, and we aren't finished yet! Only seventeen pages more to discuss. And yeah, still some shockers to come.
Aaron10 hours ago
Let's be clear the entire RTF is directed at one person.
Kazem Kazempour, CEO of Amarex!
The letter is professionally addressed to Kazem Kazempour specifically in the FDA opening address. His name is in the heading as well as the introduction.
Let's be clear, nowhere does the FDA reviewer mention NP nor anyone specific besides Mr. Kazempour! Everything the FDA reviewer states when addressing the "you" in this RTF is directed at Kazem Kazempour, CEO of Amarex.
I establish this distinction for a reason. This RTF is excoriating and the person being excoriated is the head of Amarex!
It says: "...as we told you in our December 16th, 2019 correspondence..."
This is in reference to the many deficiencies of the RTF and the reviewers frustration is that he guided Kazem Kazempour ("you"
months earlier as to what needed to be done and Kazempour didn't follow the instructions! The FDA reviewer notes that the Date referenced above is the SECOND TIME they have discussed the subjects such that his time was being wasted "Despite the specific advice above, which echoed the advice we provided you on January 22, 2019...the BLA only includes a 2 page "rationale for dose section that is identical to the rationale (previously) provided... which we told you in our June correspondence is insufficient!"
Digest that last sentence. The FDA reviewer has actually corresponded directly with Amarex and specifically Mr. Kazempour in June of 2019, told him his work and submitted material from January was insufficient, then echoed that information in December and now is pointing out that Mr. Kazempour has simply submitted materially the same deficient information!!!
Take a look at page four here! Nothing circled. Read it all! It's Kazem Kazempour describing to the court in the current Amarex case what his qualifications are!
Thirty years experience with CRO and trial collection and he actually worked for the FDA as a senior staff member overseeing clinical trials!!!!!
And yet an FDA reviewer has to point out multiple times that he isn't doing what is required even after multiple meetings? What excuse could there possibly be for the head of a CRO with actual FDA inside experience to not understand the FDA reviewer request?
Amarex says Cytodyn owes them $14 million!
Remember, it's not Amarex that is suing for their money but Cytodyn that is filing arbitration. NP claims Cytodyn should not have to pay for work not performed.
And the first piece of evidence handed to the court? An FDA letter where an FDA reviewer says he has advised Amarex (CEO Kazempour) multiple times on what is required over a fourteen month period and Amarex didn't do the work!!!!
This is Amarex argument? It's NP fault that after fourteen months and multiple requests and correspondence from the FDA Amarex failed to do it?
Let's see how this works for the current lawsuit and the arbitration.
Oh, and we aren't finished yet! Only seventeen pages more to discuss. And yeah, still some shockers to come.
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