(Total Views: 686)
Posted On: 10/27/2021 12:31:26 PM
Post# of 154001
What the hell did Amarex do for all those millions of dollars over those years? Wouldn't most of those errors fall on the CRO, that is Amarex?
As an example, the FDA appears to have even had to tell Amarex that:
Isn't this what CytoDyn hired Amarex to do?
In the end, I am not sure that Amarex releasing the FDA Refusal to File letter in this manner is going to have the intended effect for them. If someone is going to say this all falls on the client, CytoDyn, what was the reason to hire Amarex in the first place? Amarex was supposed to know this stuff.
Blaming CytoDyn for the Amarex filing a is like blaming a client for a lawyer's bad court filing. Yes, they should be blamed for hiring a bad lawyer, but you hire the lawyer to know what the court expects.
As an example, the FDA appears to have even had to tell Amarex that:
Quote:
The revised BLA should include the following:
. . .
ii. A mock-up of your container (vial) label and carton labeling with text and graphics in PDF format. . . .
Isn't this what CytoDyn hired Amarex to do?
In the end, I am not sure that Amarex releasing the FDA Refusal to File letter in this manner is going to have the intended effect for them. If someone is going to say this all falls on the client, CytoDyn, what was the reason to hire Amarex in the first place? Amarex was supposed to know this stuff.
Blaming CytoDyn for the Amarex filing a is like blaming a client for a lawyer's bad court filing. Yes, they should be blamed for hiring a bad lawyer, but you hire the lawyer to know what the court expects.
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