With the BLA, my understanding is Amerex is workin
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Posted On: 03/26/2020 6:40:11 AM
With the BLA, my understanding is Amerex is working on putting in the format required my the FDA, which was different then the format they wrote originally. And adding the additional FDA requests, just a couple weeks ago.
With Cov-19, they have 4 emergency patients injected and are working with the FDA on getting the phase 2 IND approved, bringing in Lalezari to be part of that equation.
I don't think they have slowed down on either count, imo. But I am looking forward to the BLA being complete, like everyone else, that should silence a lot of criticism currently, a lot of which NP brought on himself for giving these moving timelines.
With Cov-19, they have 4 emergency patients injected and are working with the FDA on getting the phase 2 IND approved, bringing in Lalezari to be part of that equation.
I don't think they have slowed down on either count, imo. But I am looking forward to the BLA being complete, like everyone else, that should silence a lot of criticism currently, a lot of which NP brought on himself for giving these moving timelines.
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