MiamiGent Member Level Wednesday, 11/10/21 05:34:48 AM Re: twiz0019 post# 39348 0 Post # 39353 of 39372
INO Inovio is not conducting or planning to conduct Phase Three testing in the US, to my knowledge. If Inovio were being allowed to proceed to Phase Three testing by the CDA, I'm pretty certain Inovio would be doing that, as the FDA approval is looked upon as having passed a high bar, helping along success for a new drug. Approval, say in Tobago, would not carry the same weight.
INOVIO Receives U.S. FDA Authorization to Proceed with INNOVATE Phase 3 Segment for its COVID-19 Vaccine Candidate, INO-4800, in the U.S. BY PR Newswire — 8:00 AM ET 11/09/2021
PLYMOUTH MEETING, Pa., Nov. 9, 2021 /PRNewswire/ -- INOVIO , a biotechnology company focused on bringing to market precisely designed DNA medicines to help protect people from infectious diseases and treat cancer and HPV-associated diseases, today announced that the U.S. Food and Drug Administration (FDA) provided authorization to proceed for INOVIO's INNOVATE Phase 3 Segment for its COVID-19 Vaccine Candidate, INO-4800, in the U.S. The FDA has lifted the partial clinical hold following the FDA's review of additional non-clinical, clinical, and device information provided by INOVIO.
My message was Less than 24 hours after the announcement.