The U.S. FDA has accepted Spectral’s PMA application for PMX. The application is supported by the Phase 3 TIGRIS trial, which met its primary endpoint and demonstrated sustained survival benefit through 12 months.
👉 https://t.co/zZrOzagUwe
#Sepsis#SepticShock#CriticalCare
The submission is supported by data from the Phase 3 TIGRIS trial, with full 90-day results published earlier this year in The Lancet Respiratory Medicine.
Read the full press release: https://t.co/aR1mvEuVMP
#Sepsis#SepticShock#CriticalCare $EDT.TO
@SpectralMedical@SpectralMedical can you guys provide an update regarding the FDA submission? It's being pushed back a couple of times and last time it was late April / early May. Thank you!
@davidalter It's ridiculous! They always say Championship starts at the top. Why can't we ever get good management? Ownership is the issue here. It's such a sad day and now Sundin will be remembered for a shitty manager
TIGRIS Phase 3 results:
“Publication in The Lancet Respiratory Medicine reflects the scientific rigor of the Tigris trial and the strength of the data supporting these findings,” said Dr. Matthieu Legrand, corresponding author of the Tigris manuscript..."
https://t.co/1itr3KnhaP