Replies to post #104277 on US Stem Cell Inc (USRM)

[Dragon Lady]

This is an easy win since USRM did not do anything wrong. They merely remove cells from a patient, manipulate them, and then return them back to the same patient. Not rocket science and this procedure is no different than Dialysis treatments imo. Where they take your blood out, manipulate it , and return it to your body. Same concept. easy win! USRM will be great again!

Absolutely Cptchem - that is 100% correct IMO too !!

Also, another key part of the word/wording in the FDA regulations being argued in the Appellate brief by USRM is "SAME DAY SURGICAL EXCEPTION" - as in, it all must take place in the same day/same location and also "HOMOLOGOUS" which you describe - taken from ONE PERSON then replaced into SAME PERSON and $USRM and SVF (Stromal vascular fraction aka fat derived stem cells = that) + "Minimal manipulation" as you described above and they meet that too !!

Another analogy to your dialysis scenario, and the one the $USRM A-TEAM MEGA POWER LEGAL TEAM is using, is a common, done 1000's of times a day across the USA "VEIN GRAFT" :

The surgeon (often for heart procedures) takes a piece of a still healthy vein, usually from the thigh area in heart bypass - and REMOVES IT FROM A PATIENT !

The surgeon cuts it, snips it, trims it, they then wash and clean it with saline etc. Off to the side, in the same operating room, ON THE SAME DAY (just like USRM does when they take a small fat sample, IN THE SAME ROOM and FROM THE SAME PATIENT and extract cells from same for same patient !).

The surgeon then RE-IMPLANTS (exactly as USRM does) into the same patient - but wait, DOES THE SURGEON PUT THAT "MODIFIED" PIECE OF VEIN BACK INTO THE THIGH to be a "thigh vein" and IS THE VEIN THEE EXACT "VEIN" as when it was removed ??????

NO IT IS NOT !!!

The surgeon sews that vein graft "new piece of vein" into the patient's HEART AREA to now become a "HEART VEIN" (not a leg THIGH VEIN !) and it's a different length, has been reshaped and resized from when originally removed, was washed and cleaned up, etc.

BAMMO - that exact scenario is one of the ones the USRM legal team put into the APPELLATE COURT brief- and I think a brilliant one. BECAUSE a "vein" falls under "TISSUES AND CELLS" definition same section of regulations as you got it, STEM CELLS !!

I think this is a no brainer as you stated - and IF THE APPELLATE COURT REVERSES this and especially flat-out says, "FDA YOU HAVE NO CASE and NO REGULATORY STANDING HERE" per your own laws, NOT THE TWISTED few select words you tried to manipulate against TWO, TWO selected clinics/firms out of thee entire USA - then $USRM are going down in the history books and will be the SHOT HEARD ROUND THE "STEM CELL/REGEN MEDICINE" WORLD !!

$USRM will make a flash fire of national news - instantly !! NY Times, Washington Post, Los Angeles Times, CNN, FOX news, every major medical journal, 100s of law blogs, academia sites, med research sites and on and on and on !!

How high can we trade then - when they can FLIP THE SWITCH and rapidly re-start their clinic business and will likely have institutional investors lining up at their doors - I think it will easily blow by the old highs of the 20 cent range it had prior to the FDA BS, easily !!

For me, it was COVID that changed it all - I just "read the legal landscape" and how we're in a MASSIVE SEA CHANGE of how the Congress and courts and so, so many institutions now view RIGHT TO TRY and LEAVE IT TO A PATIENT AND THEIR DOCTOR AND GET THE FEDS OUT IT and WHY NOT TRY IT IF IT WORKS etc.

There will need to be some "regulation" but I think it will be a STATE'S RIGHTS ISSUE - let the local state's regulate it as they see fit.

Clinic "licenses" maybe (you need a license to cut freaking hair in many states - woop dee doo, USRM just gets the license for each clinic), states will use their already existing medical licensing and review boards, the common civil lawsuit and insurance will be used if someone is harmed or feels harmed which is how nearly all "medical mal practice" is handled today, NOT the FEDS IN DC STOMPING in, etc

ALSO: IF this gets the FDA JACK BOOT OFF IT - it's likely that people's MEDICAL INSURANCE POLICIES "might" start to pick up at least PART OF THE TAB on some of these procedures down the road = the sky is the limit to USRM growth !

Good luck - this is in the final stretch of this long FDA legal BS.

https://www.pacermonitor.com/view/4ZUDN7Y/USA_v_US_Stem_Cell_Clinic_LLC_et_al__11cae-19-13276__11013175.0.pdf

THAT LEGAL BRIEF/APPEAL RIGHT THERE LINKED ABOVE = USRM FOR A MASSIVE WIN IMO - it's a WRECKING BALL ON THE FDA and the bullshit LOWER COURT "SUMMARY JUDGEMENT". It's CRYSTAL CLEAR ON "the law", it's tight, short and makes CLEAR the FDA "made law" where none exists !!



http://us-stemcell.com/

http://us-stemcell.com/clinical-trials/

http://us-stemcell.com/products/

[TheWhigs]

Its the "manipulate them" part which the FDA says is what USRM is doing which makes it a drug.

That being said, I agree with you. IMHO the FDA are wrong and USRM will win (hopefully).