If not https://www.businesswire.com/news/home/20230626834673/en/June 26, 2023 09:00 AM Eastern Daylight TimeTSOI/Dixon are required to file a 8k or @ the very least a detailed PR as whether approved or rejected as it is considered a Material event.by the SEC after a public release. 90 days yay or nay as that time limit is set by FDA
Retsehc Sep 18, 2023 11:44 AM $TSOI Hi @thomasichim! Should we expect to see JadiCell for ARDS listed in this database by Sunday? 9/24 will be 90 days after the filing accessdata.fda.gov/scripts/... Search Orphan Drug Designations and Approvals https://www.accessdata.fda.go
ThomasIchim Sep 18, 2023 12:18 PM @Retsehc @thomasichim $tsoi if it gets approved, yes
Codycrusher Sep 18, 2023 1:17 PM @Retsehc @thomasichim I’m praying for the approval too, I am curious what would happen if general ARDS doesn’t get approved by Sunday? Would that mean TSOI wouldn’t have a phase 3 general ARDS anymore or would they have more hoops to go through and restart the 90 day cycle in order to get it approved and the trials underway, many people including myself are excited to see general ARDS trials get underway hopefully sooner than later and toward BLA, it’s a important thing. Bullish
Transparency & Truth(s) yes would be a new concept yet one required by the SEC