Replies to post #104401 on US Stem Cell Inc (USRM)

[cvinvestor]

Zues, thanks for sharing this. I hope examples like this and arguments like DragonLady's are in the briefs as today's rep by USRM lawyer was disappointing.

Hoping for the future.

[Dragon Lady]

The skin graft example provided by the FDA was very weak. When we do tendon grafts we also dissect muscle tissue as tendons attach muscles to bones. The muscle tissue is not good for grafting purposes and is cut away from the tendon on a back table as part of the graft prep. In this process we alter the tissue as needed and then return it back to the patient in a different part of their anatomy (hamstring tendons used for ACL recon in the knee for example). The FDA has no oversight with autologous tissue related procedures.

When patients receive autologous blood transfusions (transfusions of their own blood) during surgery the blood recovered from suction is sent to a machine that cleans and then separates red blood cells from the fluid containing, fat, bone particles, and saline, and then returns scrubbed red blood cells back into the patient via transfusion. Again, the tissue, or in this case blood, is altered before being returned to the patient. And because it is blood products, there is no single destination within the body as blood circulates everywhere.

Personally, I think the judges have already made their minds up per the written brief previously provided and the hearing was mostly a formality. I expect them to send it back for trial. We will see.

AMAZINGLY GOOD EXAMPLE Zues, spot on !!!

They should have had you in the room as back-up to take the FDA kid to the woodshed with those simple to understand facts.

Damn, it's that EXACT kind of "lay person level" explanation these judges need and must hear, if they are even slightly confused by all the FDA jargon and smoke n mirrors !

I hadn't even thought about blood- damn that is good info !

How bout dialysis, scrubbing out the toxins and re-introducing "modified" new and better blood back to same patient, same day?

DRUG according to FDA, right LOL !!!

Yeah - you could have nailed their hide to the wall with those two additional examples above, just smoked um in front of that panel of judges.

COMMON SENSE = the BEST DEFENSES !!

Keeping it at a level in which you figure you could walk into a room of non medical people and non FDA attorneys and explain it to them - and at least 75% of them would get the majority of what you're explaining, as in "get it" to to the bottom line and "see" the RIDICULOUSNESS of something like "DRUG" being inserted into the argument !!

[Dragon Lady]

The skin graft example provided by the FDA was very weak. When we do tendon grafts we also dissect muscle tissue as tendons attach muscles to bones. The muscle tissue is not good for grafting purposes and is cut away from the tendon on a back table as part of the graft prep. In this process we alter the tissue as needed and then return it back to the patient in a different part of their anatomy (hamstring tendons used for ACL recon in the knee for example). The FDA has no oversight with autologous tissue related procedures.

When patients receive autologous blood transfusions (transfusions of their own blood) during surgery the blood recovered from suction is sent to a machine that cleans and then separates red blood cells from the fluid containing, fat, bone particles, and saline, and then returns scrubbed red blood cells back into the patient via transfusion. Again, the tissue, or in this case blood, is altered before being returned to the patient. And because it is blood products, there is no single destination within the body as blood circulates everywhere.

Personally, I think the judges have already made their minds up per the written brief previously provided and the hearing was mostly a formality. I expect them to send it back for trial. We will see.

THIS X 1,000 folks !!

THIS is why the FDA is going to lose in CA IMO (trial STILL set for Jan 26 next week "on the docket") and why the 11th Circuit (FL, GA, AL) will then remand the USRM case at which point they will have the CA case as "new case law" and the entire FDA JACK BOOT OF BULLSHIT vanishes in short order.

https://www.pacermonitor.com/public/case/24469480/United_States_of_America_v_California_Stem_Cell_Treatment_Center,_Inc_et_al

Read pages 11 and 12 or so of the CA judge DENIAL OF FDA MOVE FOR SUMMARY JUDGEMENT = exactly the "thought process" and SIMPLE FACTS written above:

https://www.courtlistener.com/recap/gov.uscourts.cacd.709831/gov.uscourts.cacd.709831.84.0.pdf

AFTER THE FDA IS REMOVED from "SVF SAME DAY PROCEDURES" = a literal massive sea change of medical treatment as we know it will hit America as the greatest new thing in medicine in 20 to 50 years !!

$USRM is and will be one of the few and only PUBLIC TRADED COMPANIES IN THE SPACE - in biz since 1999 and public traded (formerly NASDAQ) since 2008 !

The STEM CELL/REGEN MARKET PLACE USA ALONE will be in the $100's of BILLIONS OF DOLLARS in the coming few years IF/WHEN THE FDA is quashed - which IMO appears to be imminent now !

FDA is losing huge IN THE COURT OF PUBLIC OPINION + LOSING BIG IN THE COURT OF THE "TILT" OF THE U.S. CONGRESS + LOSING BIG IN THE STATE'S RIGHTS DOMAIN and LOSING BIG VIA "RIGHT TO TRY" and similar new thinking + soon hopefully to LOSE BIG AND FINAL IN THE FEDERAL COURTS = RIP FDA JACK BOOT ON USRM AND "SVF SAME DAY SURGICAL PROCEDURES" !!