The new SA article stated that since the HIVBLA wa
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Posted On: 07/17/2020 9:01:41 AM
The new SA article stated that since the HIVBLA was in limbo that our safety profile could not be used in the event our results are great for covid as we expect they will be. He suggested that the FDA would not be able to grant us approval of any kind for that reason. Is this correct? Would additional trials for safety then be required for this reason because there’s nothing for the FDA to use for our safety profile since they have shunned our BLA for the time being?
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