Perhaps the most important FACT....Is that the EAA ( FDA 510K approved 2003 ) was NOT used in the Euphas phase 2 Italian study. I'm quite hopeful that based on the FDA's positioning of the current TIGRIS phase 3B, that we are able to take the best of the phase 2 Euphas and of course the 179 ( 178 + 1 ) patients from phase 3 Euphrates and mix a cocktail that benefits both patients and investers. I've spent a good amount of time understanding the data in an attempt to apply it to my own personal "risk/reward" scenario on this tricky little Canadien play. Please feel free to discuss any of the past "FACT" as apposed to childish and completely purposeful back and forth attempts to cover said "TRUTH"
Bear in mind, my understanding of this play dates back to the original MEDIC STUDY that allowed the journey to begin. This MEDIC STUDY, was analysis of 843 crtically ill patients and their outcome as it relates to their endotoxin load ( AKA EAA level ) as measured by our FDA approved EAA diagnostic. The MEDIC Study told us that elevated endotoxin levels ( .4 to .6 - .28 is normal ) led to a near doubling of mortality levels and a HIGH ( over .6 ) EAA measurement led to a near tripling of mortality. Subsequent trials ( AKA jouneys ) have validated the now 20 year old results of the MEDIC study.
Phase 2 Euphas;
Terminated at patient 64 of the 128 proposed, because it proved to be "too effective"
A 21% absolute efficacy in a country that already had PMX approved ( Italy )
"Unethical" to finish trial - ethics committee HALTED the trial.
It's the STIG's opinion that these were "translocation patients", the same 59 translocation or "culture negative" patients in our phase 3 Euphrates trial provided the exact same 21% absolute efficacy.
21% absolute is a "stunningly good" result in a critical care environment...with virtually NO safety issues.
And we wonder why the personal attacks and COMPLETE BULL exists here for well "decades"
Prevailing theme in the content beloe - IMHO anyways ; - )
Let us review our current situation;
** COVID19 Trial - I'm slotting this one in own my own accord. Given we are fast approaching the 1 year mark of our trial, have added an additional site and it was only slated for 75 patients...we may get some update soon. I'm wondering whether survivors receiving PMX fair much better on organ damage...IN PARTICULAR "AKI", we know PMX reduces potential damage to the kidneys..let's see what our Covid19 benefits are...we also know the the EU has produced some significant benefits from PMX usage...curious too, does the 3rd potential filter play a role??
* EAA - Wholly owned and FULLY FDA approved diagnostic ( the "nostic" in our precision medicine "theranostic" approach ) As per the results of the phase 3 Euphrates Trial, the KEY to optimal efficacous use of the PMX blood filter.
* SAMI - FULLY FDA approved the pump / device, a portable dialysis unit. Important to know that our rights, expand beyond NA to global when used in conjunction with our PMX ( Toraymyxin ) blood filtration device.
* PMX ( Toraymyxin ) approved globally, used on over 200,000 patients, mainly the EU and Asia ( especially Japan )..we are in the final leg of FDA approval, FDA phase 3B, we are using about 40% of our phase 3 data / patients to assist in the completion of our goal of FDA approval. Most importantly, it is an "Open Label" trial that allows our PMX to be used on 2 of every 3 patients This is a good bit of insight into the FDA's thoughts and trust in what we are attempting to approve. This is a life and death situation with a proposed therpay being offered on a 2:1 ratio.
*DIMI - our "state-of-the-art" answer to ease of use dialysis in a wide variety of settings, including a patient's home - DIMI is FDA approved, awaiting a small study to allow full patient driven home use - similar Canadien approval said by management to arrive "any day now".
Baxter - an ongoing PMX relationship that has to date added 6.5M CAD to our bank account with NO EDT company valued surrendered to achieve the milestone. They are keen to be our "sales partner"
Happy weekend friends!