Replies to post #105015 on US Stem Cell Inc (USRM)

[Dragon Lady]

Well: Oral Arguments Were Jan 13, 2021 -

So: (we know the court will only publish an opinion when "open" = no weekends, no holidays and only during court "business hours" which I think is about 9 AM to 5 PM eastern for the 11th circuit?)

2-13-2021 = 30 days

3-13-2021 = 60 days

4-13-2021 = 90 days MUST PUBLISH AN OPINION BY THAT DATE per law !

I should have been clearer. I apologize. I agree that it would be a win in the short term if the appellate court were to reverse and remand the district court decision for summary judgment. USRM would then have their day in court with a bench trial.

My expectation is that the higher court decision to RR will be based on at least in part that the current FDA guidelines are ambiguous. And as such, they require further review as it relates to what qualifies as tissue manipulation. What is it about SVF that puts it into a different classification from other tissue harvesting procedures for same surgical procedures that do not come under FDA oversight?

Dear FDA. Please explain your legal authority to single out stem cells harvested via SVF. Thank you..:)

No worries and no apology needed :)

I totally agree- and the "MATTER OR QUESTION OF TRIALABLE FACT THAT NEVER GOT HEARD" which is really what appelate courts can "do".

What USRM is asking for in their appeal is, "PLEASE REVERSE THE HASTY MOVE TO SUMMARY JUDGEMENT and let our expert witnesses be heard and let us prove that the FDA is conflagerating two different sets of codes and regs AND tossing-in a guidance document as the cherry on top of the mess AND is mis-defining and contradicting their own regs that stood for years, via altering one or two words as to what the meaning of the same hct/p's is or are" blah blah blah.

And I'm pretty darn sure that is where Marcus was driving and really going when he got hot and heavy on the FDA attorney - the "Wait, wait, hold it just a second there pardner. USRM had, had, had an expert witness and I'm reading their opinion right here, though I don't claim to understand it all, but let me read some of it to you. It says, "SVF CAN and DOES provide more than cushioning and in fact is known to provide anti-inflammatory and and wound healing affects" blah blah it's right here in my hand, and this was a medical expert that was never even heard by the court ?

So, Mr FDA (Marcus speaking) IF, IF that expert witness had been heard, "Are you telling me that nothing in the FDA's stance or position could possibly have been altered or changed? AND, are you telling me this entire case hinges on thus, these two words "the same" and nothing more - that SVF has not merits to what they claim it can do, let alone as in any same day procedure, obviously comes out with some goo, but they clean it up and the person's same cells are going back in, again, according to expert testimony that they never got to present as YOU Mr FDA moved for summary judgement in an awful big hurry, did you not?"

Almost as if Marcus was saying, "Why you so worried FDA if this is a cut n dry slam dunk as you claim it is? Why not let the defendant have a day in court then and let a bench trial take place and let these matters be hammered out and at least heard? What's so bad about that?"

And that - is where I think they rule and REMAND = again, it ain't "OVER" but the 11th circuit will strike the "SUMMARY JUDGEMENT" and order "MATTER OF DISPUTED TRIALABLE FACT EXISTS" and "have at it in the district court" both sides can duke it out on science and expert witnesses above my pay grade as a judge, but that's why we have court, correct Mr FDA ?

So....ON A REMAND = STILL A LONG WAY TO GO TO "FINAL DECISION" on "IS SVF A DRUG OR NOT" and the EXACT SAME ISSUE is going to be "heard" in CA with a judge who at least has sent a few "smoke signals" IMO, that he ain't real fond of the FDA's twisting of their own regs - and massive stretch to reach the conclusion(s) they've reached on this "IT IS A DRUG" bullshit.

BUT, BUT, BUT - NEVER underestimate the power of BIG PHARMA and/or JUST PLAIN STUPIDITY OF "THE COURTS" and FDA to somehow prevail and BONE UP THE MOST OBVIOUS ISSUE ON THE PLANET - it would be more the "normal" that they F this up than get it right, unfortunately and sadly for this nation and citizens.

ONLY ACE CARD = TWO PARALLEL CASES = one says NO and one says YES and now it's a SCOTUS MATTER and/or the FDA just punts - as they're LOSING IN THE COURT OF PUBLIC OPINION and at the state levels.

PROBLEM IS TIME - civil matters during COVID are even worse than usual - and "usual" is PATHETICALLY SLOW and a mockery of the "RIGHT TO A SPEEDY TRIAL" BS they taught us in school -

That's about "it" as to where this puppy is parked and sitting IMO - we wait and then ON THE LUCK OF A REMAND things will be brighter - but still not a "win" until a bench trial true and final "win" IF that occurs.

TIME - lots of time can pass in the meantime, the courts are being beat in speed races by two legged old turtles named "Lucky" as of right now !!