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Posted On: 08/26/2021 5:22:51 AM
Post# of 153941
Re: Goosebumps #101603
Quote:
We need to establish a drug safety in a BLA submission that shows a lot of time and patients safely taking our drug.
Safety for a drug is established in a phase 1 trial (or in leronlimab's case sometimes starting in a phase 2 because safety is already established). Safety has been proven in multiple HIV trials going back to Progenics, 3 Covid trials and the 1b trial in mTNBC trial itself.
Quote:
be heads above any other drug that receives a LH’ers EAU.
Longhaulers syndrome would not qualify for EUA status.
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