(Total Views: 634)
Posted On: 04/11/2023 5:09:26 PM
Post# of 154492
I just re-listened to that section and it sounds like the FDA wants to know what our plans are going forward with HIV.
The supplemental request was for a general organizational plan for the HIV program going forward. We submitted that along with a benefit/risk assessment for HIV patients and the FDA then responded by wanting either the new HIV protocol that the company plans to undertake once the hold is lifted or clarification that the HIV program will be shelved.
So the hold still has be lifted but the FDA wants details of what we plan to do with the HIV program, if we plan to do anything, once the hold is lifted.
The supplemental request was for a general organizational plan for the HIV program going forward. We submitted that along with a benefit/risk assessment for HIV patients and the FDA then responded by wanting either the new HIV protocol that the company plans to undertake once the hold is lifted or clarification that the HIV program will be shelved.
So the hold still has be lifted but the FDA wants details of what we plan to do with the HIV program, if we plan to do anything, once the hold is lifted.
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