Remember phase 2 Euphas was "stopped early" ; - )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!