Ken Kengatharan, Ph.D. Profile picture
Bio(+)tech(+)engineering R&D | C{X}O | BOD | Atheneos Ventures | Auxesia Orion | Helios Orion | +2 more | @Stanford | Focus: #orphanization | Views+RT = my own
Nov 21, 2020 6 tweets 6 min read
@Pharma_Pro @SteveFDA @US_FDA Agree, Daniel. But, isn't there a history of BLAs/NDAs being approved for drugs meant to treat large population without AdCom mtngs/over-ruling AdCom vote? I am asking for issuing EUA for the 2 vaccines asap with only FDA review so that they could be started to be given asap..1/ @Pharma_Pro @SteveFDA @US_FDA ...and still have the AdCom meeting on the 10th Dec (to decide whether to keep or revoke the EUA) as well as in say 6 months to determine if the EUA should be kept/revoked based on real-world safety and effectiveness data, and even prior to a BLA, which is rarely revoked..2/