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Posted On: 11/27/2023 10:39:24 PM
Post# of 153905
Ohm,
I understand what you are saying. I guess nothing is an absolute, especially if it involves the government.
In reading the guidelines in responding to a clinical hold, I found this interesting;
D. Can I address nonhold issues in my response to the Agency’s clinical hold letter?
No, even if the Agency includes nonhold issues in the clinical hold letter, you should ensure that the complete response to a clinical hold letter contains no material related to issues other than the IND clinical hold. If you wish to address any nonhold issues raised by the Agency, please do so in a separate amendment or letter.
So does that mean Cytodyn has to create a separate response to FDA’s questions on the HIV BLA?
I understand what you are saying. I guess nothing is an absolute, especially if it involves the government.
In reading the guidelines in responding to a clinical hold, I found this interesting;
D. Can I address nonhold issues in my response to the Agency’s clinical hold letter?
No, even if the Agency includes nonhold issues in the clinical hold letter, you should ensure that the complete response to a clinical hold letter contains no material related to issues other than the IND clinical hold. If you wish to address any nonhold issues raised by the Agency, please do so in a separate amendment or letter.
So does that mean Cytodyn has to create a separate response to FDA’s questions on the HIV BLA?
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