RE:It's only been 28 years ( see 1994 )That said, "DaViking" from Edmonten has ONLY been posting NEGativity here for 22 years : - (
Fore, score and 28 years ago the "SOFA" scoring system was developed by the EU society of critical care med. At the same key moment in time the PMX filter was approved by the Japanese Medical Sytem AND perhaps most importantly, the EAA ( Endotoxin Activity Assay ) was invented by our former CEO and his brilliant colleague. Seems 1994 was a most important moment in the history of our "theranostic" approach to helping the critically ill with Endotoxemic Septic Shock.
ALL of Spectral's KEY products are approved for use in Canada;
EAA - wholly-owned diagnostic AND FDA appoved 2003
PMX - Canada Health approved 2003 - currently in a FDA phase 3B TIGRIA trial AND using 179 patients from the earlier phase 3 Euphrates that was initially advertised as a FAILURE ( 66 months ago )...100 MILLION shares printed since said "FAILURE" announcement
SAMI - portable ICU blood pump - FDA approved in 2018
DIMI - portable / Home dialysis unit FULLY approved up in Canada and FDA approved here since 2020 ( FDA approval for in hospital / clinical use only, waiting on IN-home approval )
* DIMI waiting sum ~ 19 months AFTER FDA approval to run a 6 week 35 person study in clinic and in home to get FDA approval for in home use..to match what Canada ALREADY has been granted.
* THE DELAYS are "PAYING OFF" as in the 64 MONTHS of voluntary "delistment" to the US OTC PINK parade where we hardly trade and MOSTLY show as SHORT..Hmmmm???
DURING our little "FDA and Canadien approval party" our "analyst" ( aka CEO and former board member's company ) has reduced their target 4 TIMES and is delivering more dire news that includes talk of dilution with a stronger than usual current cash position?? I'm confused, but not really!
I was looking at potential UPdates due and in sum cases...well over-due for our public company.
* TIGRIS update on US Trials.gov - last updated Mar.22/22 BUT, it is OPEN LABEL with a 28 day mortality endpoint and the BOD, insiders AND Unknown others know what "EXCEEDING EXPECTATION" actually means...WE, retail shareholders have NO IDEA where the efficacy numbers are sitting..."THEY" do.
PMX - Canada Health approved 2003 - currently in a phase 3B FDA study, NOW 66 MONTHS after the completion of the phase 3 trial that was advertisied as a FAILURE..now 179 of the phase 3 patients carry a data 75% weighting in our Baysian designed phase 3B where 2 of every 3 patients will get the PMX in a life and death 28 day mortality primary endpoint
* Disclosure of detail released in San Diego on the phase 3B TIGRIS, BUT NOT shared with the public
* Disclosure of Kellum's last presentation at Vicenza, his Saturday morning appearance at the end of Vicenza remains a "redacted treat" for special invitees
* Ronco and Walker's "keynote addresses" at the TIGRIS pep rally held 8 weeks ago. It would appear this too, was detail that is best "redacted"
* Baxter partnership - redacted detail, the real benefit of the Baxter deal was for ANYONE that participated in the $$ raises over the last 2 years. The 6.6 M CAD of revenue was split into 108 pieces ( stretched out over 9 years ) WHILE and unexplained 1.7M CAD "legacy FEE" was charged to the quarter and the "dilution party" began..100 MILLION shares later...we achieve 15 cents CAD in December 2021 under the watchful eye of our CEO's former companie's "analyst coverage"......"I DON"T think so Donnie"!
* DISCLOSURE of amendment update for Dialco. We were told on December 2 2021 that the amendment was to allow patients using the DIMI in home, extended or continued use of the state-of-the-arte device beyond the trial. We were told this amendemnt would come in mid December..it came two weeks ago and it arrived with NO disclosure.
* 18% absolute efficacy achieved in the phase 3 Euphrates trial ..the subgroup?? This was disclosed 66 months ago ( October 3rd 2016 )..we've yet to recieve ANY detail on this most important figure
* Alter-cyte activity - what is going on with Pittsburgh based Altercyte? 49% owned by Spectral and an additional 2% owned by an undisclosed director. This datrs back to 2012, we know NOTHING about this asset that belongs to shareholders.
Seems the swiftest action was the creation of "Dialco" and it's abrupt move away from the Spectral connection. I was curious about just why Dialco was created so quickly and I suggested to fellow "STIG" members that Dialco allowed for DIMI and SAMI to be "further removed" from the EDTXF ticker symbol...sum scoffed...history tells us that having these approved and black and white type assets attached by a "TAB" has clearly been important on our path to 15 CENTS ( December 2021 )...and that is CAD ( ouch ; - ( )
LOVE the company.."wish I owned more".....
BUT bear in mind..."THEY OWN IT ALL" ...in 2008 a total of 1.2M shares traded for the entire year ( 365 days ), since that time, ALL share creation has remained within the "inner circle of trust" ...they have been "placed" ... NOT offered for public consumption.
ALL in my most humble, yet rather most educated retail shareholder opinion. Do your own due diligence and feel free to challenge where inconsistencies are discovered. Consult a real pro on matters of $100 or greater. This afterall is purely spectralative- IMHEO
Bon appy,
Tom