First of al, I agree with all of your concerns Hul
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Posted On: 04/25/2023 8:41:24 PM
First of al, I agree with all of your concerns Hulk.
But I don’t necessarily agree that this FDA was unexpected. I think it’s a positive development. In fact, I believe, this indicates that the FDA is going to lift the partial hold in the HIV (only) indication.
It means, IMO, that they are close to doing so. Factoring in AAV en vivo research and allowing CYDY’s past HIV data, with Risk/reward aggregated safety data to proceed, I think the FDA is doing a forward look. This makes sense for them to do after all the Amarex, Nader, shenanigans.
It’s what I’d demand. After all. And I think it’s a positive development. Might take a little time to submit the forward-looking protocol. To me it feels like progress.
But I don’t necessarily agree that this FDA was unexpected. I think it’s a positive development. In fact, I believe, this indicates that the FDA is going to lift the partial hold in the HIV (only) indication.
It means, IMO, that they are close to doing so. Factoring in AAV en vivo research and allowing CYDY’s past HIV data, with Risk/reward aggregated safety data to proceed, I think the FDA is doing a forward look. This makes sense for them to do after all the Amarex, Nader, shenanigans.
It’s what I’d demand. After all. And I think it’s a positive development. Might take a little time to submit the forward-looking protocol. To me it feels like progress.
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