got "lost in the $huffle"?
"Hard to know" .... "Harder to
HOLD" ( just like the one we
bought from Zacks ; - ) )
Does anyone have an explanation as to why global health care GIANTS failed to recognize the "limitations" of the filter...indeed, a HUGE factor in the phase 3 FAILURE..now oddly turned SUCCESS as 40% OF THE "failure" takes on a 75% weighting in the phase 3B FDA confirmatory story.
Hmmmm...still wondering why we split the 6.6 mill from Baxter into 108 tiny pieces over 9 years, or why we showed our lowest revenue quarter in years ( ~240K..special! ) even though 183K of it came from the "fun size" 108 piece aknewuity? SAMI has only been FDA approved since 2018, is that "hinge issue" from March 2015 in a San Diego still an i$$ue?
Hard to know..."harder to HOLD" RE:Re-visiting the phase 3 Euphrates trial.."Post-Hoc ?'s"
The next round of "questioning" will be in regards to the BIG GAP ( largest of ANY phase 3 subgroup) between the PMX abdominal patients and the "SHAM" abdominal patients. Please, don't misunderstand me, this was PURELY a result of the "random nature of patient assignment" as it pertians to which group they are applied ( PMX or "SHAM" " ). That said, it is another one of those 800 LB elephants in the room that MUST BE ADDRESSED as it made "meaningful impact" to the phase 3 Euphrates data. Don't be afraid to "ask questions" we are ALL here as common shareholders to better learn and understand our "loyal commitment" to this story.
First let us see some discussion around this HUGE point before we carry on with meaningless and potentially damaging discussion that appears to be "purposeful" ; - (
If the PMX filter was approved for use in Japan in 1994, and the EAA diagnostic tool invented in 1994 and FDA approved in 2003, how is it that we enrolled / treated patients with EAA levels that the PMX filter could NOT handle ( AKA - levels that overwhelmed the filter )? The parameters of the diagnostic have been in place for over 2 decades ( see 843 patient MEDIC trial ) The filter itself used on over 300K patients as of today and ~ 200K patients at phase 3 commencement.
.28 is normal, .4 to .6 is elelvated and > .6 is HIGH
In the 7th grade I ran a science fair project that called for the transfer of liquid from a closed container into a fish bowl. I over estimated the capacity of the fish bowl and the liquid spilled all over my principal's trousers and suede shoes. I "FAILED" the project, BUT the principal told me "not to go away", that my project was "robust" and in the 8th grade I "repeated the project" and won 1st prize in my class. I simply ensured that my fish bowl had adequate capacity, I REDUCED the size of my closed container. FYI, that same principal stepped back an additional 1 yard and wore rubber boots during that 8th grade "Do-Over"
Bon appy,
Tom
ps - I had to pay for new trousers and new shoes for the principal...a small price to pay, as my project is now "SOC" or "standard of class" in many middle school fairs