RE:RE:RE:Spectral's Covid 19 "Expanded Access" trial due for results!Todays news from Bangkok bodes well for some NA positives, especially when you add the buffet items from Italyaly...and "what-have-you" ...patience my friend ; - )
I agree on the need for an update to the Covid19 trial being run at 3 sites in three different states. Soon it will be 5 years from the end of the Euphrates phase III, the trial with the "top line" results that took us from $2.07 to 18.5 cents CAD on the well attended October 3rd 2016 announcement. Strange but true, approximately 40% ( 178+1 patients = 179 ) of the data gathered in the phase III "disappointment" is now to be largely used in the confirmatory phase 3B/4 final decision. Covid or no Covid, nearly 5 years after the phase III finishes and we have 20 patients enrolled in a 2:1 ratio medical device confirmatory trial with an already FDA approved diagnostic ( EAA ) guiding all decisions in regards to the completely safe filter's application. Smells like the FDA doesn't need to see much more. 179 patients from phase III, 64 patients from phase II ( stopped because it worked too well ) ~ 400 patients in the Euphas2 registry documenting usage / experience around the globe. Icing on the cake for the "septic journey" would be the over 300,000 documented PMX patients since 1994 and you have the opportunity to "data dive" like no other "theranostic" approval process in history.
Yeah..unless we are claiming CV19 has disrupted our CV19 trial, we should probably hear somthing from the trial soon. What is PMX doing for CV19 patients, especially those unfortunate effort to become severely septic or especially burdened by "endotoxemia"? Four months after the trial began, the FDA saw it fit to add an additional location. This would seem better than a call to "suspend" a trial. You never know, maybe we are getting useful data in the CV19 trial to assist us in reaching a decision? Europe seems to be finding benefit...are oui?
Buena suerte,
Tommy