Safety Profile? I heard the two cardiac safety iss
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Posted On: 03/31/2022 10:32:47 AM
Safety Profile? I heard the two cardiac safety issues in Brazil, and am hopeful they will prove to be unrelated to LL IV.
I also heard Amarex wasn't tracking safety (was it in HIV trials) going back some length of time and will have to be verified for the FDA.
Does this mean we may not have the safety profile we thought we had? Did we state over and over we had no SAEs all the while that Amarex wasn't tracking SAEs?
Hope not. I've invested heavily here because of the safety profile, and to not have 100% confidence in that right now is less than optimal.
Safety of LL is kindsa bedrock. Or is it? Perhaps I'm over-thinking here? Thoughts?
I also heard Amarex wasn't tracking safety (was it in HIV trials) going back some length of time and will have to be verified for the FDA.
Does this mean we may not have the safety profile we thought we had? Did we state over and over we had no SAEs all the while that Amarex wasn't tracking SAEs?
Hope not. I've invested heavily here because of the safety profile, and to not have 100% confidence in that right now is less than optimal.
Safety of LL is kindsa bedrock. Or is it? Perhaps I'm over-thinking here? Thoughts?
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