US Stem Cell Inc (USRM)

[Dragon Lady]

I’m no attorney but from what I watched, the arguments on behalf of USRM should provide a favorable outcome. I could tell by the one judge especially (Warren or something close). Although the lady seemed to have lost the panel initially, it still seemed like judges were receptive and I think the FDA loses this one.

I agree - and moreover, the WRITTEN BRIEF IS REALLY THE MEAT AND POTATOES !

The oral arguments are really for the judges to ask questions for clarity and anything confusing them, etc.

WHO DID THEY ASK A LOT OF QUESTIONS OF - thee FDA !! I'm not even sure they really asked much of anything of the USRM attorney, if I remember correctly?

I wish I had the video recorded (the audio will be on the 11th circuit website tomorrow and I'm going to re-listen to the entire thing) but the questions TO THE FDA RATCHETED UP FURTHER INTO THE HEARING - and got more pointed and questioning IMO.

The one judge (I can't remember the 3 names now either, LOL !!) - he seemed to be working on cornering the FDA "kid" (weird, where was Gural the FDA trial attorney who started all this mess? They sent this kid to argue this ? Weird to me?) - that judge zeroed in on a section and words and asked the kid TWICE, "So, IF USRM had changed this word here to another word and it read like this, DO YOU or WOULD YOU then have changed your position, not you personally but the FDA?"

Kid fumbled around. Judge asked again:

"They, USRM had medical expert testimony that said THESE STEM CELLS COULD POSSIBLY BE EFFECTIVE at such and such and not a guaranteed 100% cure. You the FDA keep focusing on some specific words claiming an absolute. Is that your position? WHAT IF THE CELLS DO AFFECT SOME ANTI-INFLAMMATORY PROPERTIES and other helpful means to assist in these various diseases, then what?"

Kid from FDA fumbled the ball profusely at that point.

ALL THE FDA KID DID - was kept going back to TWO "DISEASES" which are MACULAR DEGENERATION and PARKINSON'S and that judge I'm referring to, he pulled up a piece of paper on-camera and said, "BUT USRM HAD AN EXPERT WITNESS AND THE LIST OF POSSIBLE CONDITIONS IS A LOOOOOT LONGER THAN THAT MY FRIEND, what say you?"

In other words, the judges ALWAYS HAVE READ and STUDIED THE WRITTEN BRIEF EXTENSIVELY BEFORE HAND - and that judge he "got it" 100% IMO that the FDA was hinging this case on the "But, but, but someone got harmed in THREE CASES out of 1000's and that makes it a FDA DRUG and we need to stop it now".

Judge seemed to be saying, "Not so fast buddy, surgery is dangerous and expert medical testimony NEVER GOT A DAY IN COURT by jumping and hop skipping right to the very heavy hand of SUMMARY JUDGEMENT, let alone you guys are all boned up on conflating multi sections of your own regulations which are TISSUES and and and CELLS, and the regs does NOT say where or how the CELLS are obtained, it's not in the regs".

IF IT WAS ME and I had the chance to argue that appeal - I'd of been a little tighter if it was me- the opening by the female USRM attorney- I'd of gone REAL, REAL BASIC (Like Mickey's big hand on the clock says, kind of basic LOL!).

"Your honors, we use BONE MARROW STEM CELLS EVERY SINGLE DAY to treat cancer and a host of other things. And it is NOT FDA REGULATED AS A "DRUG". Those procedures and CELLS are in the SAME SECTIONS being argued here today, only difference being stem cells found stored in fat, versus the marrow of one's own bone and spinal column.

Now consider your honor, THEY SUCK OUT BONE MARROW FROM A PATIENT'S SPINAL COLUMN or inner large bones of the body and use that bone marrow with STEM CELLS IN THEM and then re-inject them to flow ALL OVER THE INSIDE OF THE BODY and attack cancer cells, and we don't even to this day fully understand how that works.

Now consider your honor, the FAT the FDA is so hyper focused on, it's just another place where STEM CELLS like bone marrow, where these healing cells like to hang out if you will your honor. We're just going to the water well if you will, the well with rich clean water in it, and we're getting the richest source of STEM CELLS at that well, that source.

It makes no difference your honor that FAT happens to be where those cells like to concentrate, anymore than the bone marrow is also a rich source of healing stem cells" blah blah blah. And like a surgeon uses a knife and shaping and washing, we use a VERY MINIMAL wash and clean-up procedure to get the ORIGINAL STEM CELLS which belong to the ORIGINAL PATIENT for simple re-implantation back into the SAME PATIENT and ON THE SAME DAY, just like a NON DRUG, NON FDA REGULATED USE OF BONE MARROW YOUR HONORS. That is what we are presenting and really arguing here today.
"
END OF OPENING FOR ME -

I'd of used THAT and the VEIN GRAFT of a THIGH VEIN ending up as a HEART VEIN also - you MUST KEEP IT REAL SIMPLE WITH JUDGES, they hear a 1000 different kinds of cases all day long, and are not bio-scientists, etc.

The WRITTEN BRIEF COVERS THAT - just think verbalizing it at that level would have been more potent and set the stage for the judges stronger out of the batter's box for the USRM attorney. Don't get lost in the weeds of 1271's and sub section of sub-sub section blah blah. Just tell the story of why this is simple, why it's good, and WHAT THE HELL IS THE FDA TALKING ABOUT WITH THE WORD, "DRUG" ???? Like that !!!


NO MATTER - I think AT A MINIMUM the panel sees that SUMMARY JUDGEMENT WAS A MISTAKE and was waaaaaay over-reaching by the lower court and the CA CASE is in that written brief and those APPELLATE JUDGES are darn well going to take notice that a CA Judge INSTANTLY said, "Whoah, whoah hang on a minute here FDA, we got a LOT OF SPLANIN TO DO AS RICKY SAYS TO LUCY, and you ain't even close to me issuing HEAVY HANDED SUMMARY, let alone is this a slam dunk!"

THE 11th Circuit "might" hope the CA CASE WRAPS UP HERE QUICKLY - and if the FDA LOSES THERE, then just SLAM DUNK AND TOSS the entire FDA CASE in FL.

Jan 26 (2 freaking weeks away) is STILL SET FOR TRIAL UNLESS SOMETHING CHANGES IN THE NEXT FEW DAYS IN CA !!

OVERALL = a GOOD DAY FOR USRM IMO. We're at 8 ma MILLION SHARES and now $300K PLUS BUCKS TRADED = I "think" the bigger world than just I-HUB money watched this today and sees this was FAVORABLE TO USRM !


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