“In the last CC NP stated that Dr. Ray would be
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Posted On: 04/03/2021 11:10:02 AM
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“In the last CC NP stated that Dr. Ray would be meeting with the FDA on April 6 or 7 (can’t remember) to request approval of Samsung as our distributer.”
If I remember correctly, the early April meeting with the FDA is in regards to manufacturing for the HIV BLA. The good news is that if the FDA approves Samsung as the manufacturer (I thought this step had been completed as part of the rolling review process), the eventual approval for COVID will have one less hurdle.
If I remember correctly, the early April meeting with the FDA is in regards to manufacturing for the HIV BLA. The good news is that if the FDA approves Samsung as the manufacturer (I thought this step had been completed as part of the rolling review process), the eventual approval for COVID will have one less hurdle.
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