Wonderful news! Thank god.

Cheers. GLTU. AMC$ long.

Thank you Mr. Halt! Picked another 150 shares @ $51. Oh yeah!

Love my AMC. Volume is key. Holding and adding. $26 will seem cheap soon.

GLTA

Based on what I know from the CA Stem Cell case, I like my chances here...

I see two theoretical positive outcome scenarios at play:

Scenario 1 - CA Stem Cell wins their case. The FDA has no oversight for SVF stem cell transplant procedures in CA. The ruling will be seen as a positive sign for the market. This could trigger a mini run for USRM - the first of a two legs.

Scenario 2 - USRM wins their appeal and the case is remanded - this should trigger the second leg. I have powder ready but I will wait for the Cali decision before adding. Until then...

I never tell anyone to buy. I don't promote. Do your own DD.

Addendum: "Justice Bernal's ruling will set a precedent in Cali either way but USRM's appeal is done." I should have stated that a favorable decision in the Cali case would not help USRM's appeal but it would provide a legal precedent for their defense if the case were remanded back to Florida district court.

I am really encouraged by what RICHARD JAFFE's, ESQ. has to say about the proceedings. Things are getting interesting now. GLTA.

Hello Hippycowboy. I agree that justice Bernal's decision should have great influence. But the opinion of the justice Bernal will be most impactful for CA Stem Cell and less so for USRM because we are talking about different states and jurisdictions. It would be a mistake to assume other jurisdictions will follow suit. We can only hope.

Justice Bernal's ruling will set a precedent in Cali either way but USRM's appeal is done. They can't use it as a means to support their argument (if justice Bernal were to rule against the FDA). My hope is the 11th Circuit will not have a decision before the Cali case is decided. And that the appellate judges will see merit in issuing a remand based in part on justice Bernal's decision (if justice Bernal were to rule against the FDA).

You seem quite concerned. Why is that?

Looking good for CA Stem Cell. I think the decision for that case "may" impact USRM's court of appeals decision (depending on timing). The premise of these cases are essentially the same. Why wouldn't the court of appeals wait?

Yes. I think we are on the same page. Many of the talking points raised here reflect why this case should be remanded. If only to establish clarity. Summary judgment was premature.

It does depend on the FDA’s interpretation. Their guidelines are based on interpretations. That is the crux of this dispute. The FDA continues to claim SVF stem cells are sufficiently manipulated to classify it as a drug derived from a biological product, and as such, they have the legal authority to regulate usage.

USRM needs to establish the difference between tissue manipulation via SVF and the creation of a drug. In the case of SVF, they need to prove tissue manipulation does not qualify the product as a drug simply because the process involves separating stem cells from fat where the end product – tissue remnant – is unchanged from its natural state. This is no different than intra-operative autologous blood transfusions which requires manipulation (as I have said earlier) where red blood cells are isolated from other blood products then scrubbed clean before returning to the patient via transfusion. The machine used to carry out the procedure is FDA approved, but the blood (tissue) products are not.

The underlying question here is who should have regulatory authority over stem cell tissue transplant procedures? The FDA claims to have the legal authority. But if the procedures can be reclassified as tissue manipulation without synthesis then it should be no different than any other tissue transplant procedure where FDA regulation/guidance does not apply.

The case for SVF efficacy has not been proven yet. The injunction could be changed to a preliminary injunction until a final ruling. How can the court allow a business to operate when they are defying current Federal drug laws that are intended to protect the public?

My comment had nothing to do with where laws originate. I am aware of the legislative process. The FDA enforces the law.

The FDA has authorized stem cell treatments for certain procedures. But USRM was operating outside those established guidelines. Without approval USRM was in violation of FDA policy meant to ensure public safety.

I work in medicine and have experienced the process of obtaining FDA approval for a procedure that involves a medical device (surgical implant). I have first hand knowledge. Without FDA approval you are in violation of the law - like it or not.

The FDA has changed their position numerous times in an attempt to maintain control. There is no need to rehash their arbitrary interpretation of law as it pertains to tissue transplants and SSP's. If you have read my previous posts you will see where I challenge the FDA.

It is up to the appellate court to determine whether summary judgment was justified. The injunction was the outcome. I find it hard to believe the appellate court would be willing to go beyond remanding the case back to the state supreme court. I would expect the injunction to remain until a final ruling is made as that would be most prudent.

My focus is on winning the appeal. If the injunction is lifted temporarily that would be great. But what USRM really needs is their day in court.

I too expect the case to be sent back. But I would be surprised if the 11th Circuit were to lift the injunction prior to retrial considering USRM's stem cell operations were in defiance of FDA law. If they were to lift the injunction prior to lower court testimony it would send a message that the FDA has yet to establish legal grounds for shutting down USRM's stem cell operations. I am not sure the appellate court would be willing to take that leap especially when they themselves do not fully understand the science and where "do no harm" is a mandate.

I think at this stage the appeal is about ensuring due process where both sides have equal opportunity to be heard.

I stand by what I said. Price fluctuations are meaningless for me in the setting where a single inevitable event will decide the future of a company. I put my money on the table and I'm prepared for the consequences. I use charts for big board stocks - one of many tools - but I find them very unreliable in the cesspool known as the OTC.

GLTU

Yes. Just like you've been saying all along. I understand why people say what they say...but it is really just a side show.

Daily charts are meaningless imo when there is a major catalyst event on the horizon as in the case with USRM. There might be some benefit in terms of flipping the stock or tracking consolidation but that doesn't tell you when/if a sell off might occur. Might as well consult a Ouija Board.

https://www.uscourts.gov/sites/default/files/data_tables/jb_b4a_0930.2016.pdf

The chart above shows that a civil case takes around 3.0 months from notice of appeal to oral argument and around 10 months from notice of appeal to final decision. This translates to around 7 months from oral argument to final decision.

Just look for these numbers below in the chart as it relates to 11th court under civil cases:
11th court >3.3< and >9.7< months, respectively. Very clear estimates provided based on historical fact!

Very true.

A decision will come. The relevance I see with the CA. Stem Cell case - other than the two cases being nearly identical - is that the judge in CA. ruled against the FDA's request for summary judgement. I understand that rulings for similar cases can vary widely state-to-state. But no one can deny that the CA. ruling set a precedent that other states may follow especially if California Stem Cell wins their case against the FDA. And this is something the 11th Circuit Court of Appeals must be aware of when deciding to RR USRM's case.

Let the states decide!

Everyday is one day closer to USRM court decision.

No specific due date. Historic average for appellate court opinion range in the 7 month time frame following oral argument. It is important to keep in mind that the court works at their pace. One thing is for sure there will be a ruling at some point.

I believe the higher court will do the right thing and RR this case. Injustice Ungaro's ruling was unreasonable and went against the principals of substantive due process. What I see here is a business on the brink of BK or breakout.

Watch >>> https://www.ca11.uscourts.gov/opinions

I agree. AMC is a reopening play.

I expect the appellate court decision to come in due time despite not knowing a hard date. I don't believe the case will get buried and forgotten. I will trust historic averages as a guide over any claims to the contrary.

As we all know, judge Bernal of the CA. district court ruled against summary judgement in the FDA vs. CA. Stem Cell case (a case that mirrors USRM's). It seems Justice Bernal views expert witness testimony as means to achieve due process and this is something I expect the appellate court is acutely aware of. The appellate judges themselves acknowledged they do not fully understand the science, therefore; it would seem the only way to make an informed decision would be to hear expert witness testimony as we are seeing with the CA. Stem Cell case.

I see this scenario as being similar to providing a patient with a consent for treatment. A consent is a legal document based on the science of the procedure, potential risks and complications, and expected outcome. It is intended to educate. A consent can be used as basis to seek other opinions to assist in making an informed decision - something I would hope the appellate court values.

This is how I see it. I think the chart provided in my previous post is a fairly good reference despite being from 2016 as it at least sheds some light on an otherwise grey area.

It is safe to assume there is a finite number of cases the appellate court can accept from argument to opinion within a given time period. Having to wait many months to present the oral argument tells me the court has had to manage their case load in response to covid-19. And although there is no way to know when an opinion will be posted, we do know there is at least an average time range that can be used as a rough estimate along with factoring in delays associated with (among other things) covid-19.

To anyone reading this post, it might be prudent to avoid assigning any deadline or expected dates for the opinion as this might trigger negative volatility due to shareholder fatigue.

This might help clear things up:

Hi saratg. Nice summary.

If the appeals court sides with USRM it will be the same suit just kicked back to district court for retrial. You bring up an interesting question about the plaintiff and rewording. It is entirely possible the FDA changes their language and tactics for the bench trial. The FDA might feel they need a different approach to win.

I am convinced a bench trail will happen. But I will not feel as optimistic about things if Ungaro is the presiding judge. I think she is bias or even worse.

Well said. I agree there are many legal hurdles/variables from state to state. I think we could both agree that an RR opinion from the 11th Circuit for USRM would be a great start. I will admit that I am not focused on USRM's balance sheet right now. All I care about is the decision. I will reassess after that.

Forget the court case for a moment. You said this:

FDA approval would apply if USRM was attempting to market a drug or medical device. That isn't the case here. The FDA changed their position from SVF creates a drug and are now arguing the procedure to harvest stem cells manipulates the tissue so that it is not the same tissue implanted back into the patient.

Sure that would be my first thought - move shop. Maybe incorporate with CA Stem Cell (join forces).

I edited my previous post. Might want to read it. If there is a favorable ruling in the Ca. case, I think that would carry significant influence across the country legally and politically.

If CA Stem Cell wins their case, I expect the next step would be for state and local legislation/board of commerce and medical boards to determine efficacy guidelines. The ruling would set a legal precedent that other states could follow. I think it will open the door to states adopting stem cell legislation that relies on medical board guidance as with all tissue transplants procedures not the effing FDA.

I am not sure what would happen with USRM's case if there was a favorable ruling in CA. It is important to note that when the 11th Circuit Court of Appeals RR's a case the district court is expected to start fresh at square one. So this may end up being an exercise of legal procedure and discourse. My gut feeling is that the Florida district judge would go along with the precedent set in CA but that may not happen.

I expect the decimal point will change when/if USRM is given a favorable decision. I believe that Justice Bernal's decision to deny summary judgement in the CA case which mirrors USRM's court appeal was very significant. And because of this, I am convinced the Appellate Court would want a lower court bench trial with expert witnesses to determine the outcome in the USRM appeal. Given the above circumstance, why would the 11th Circuit rule in favor of the FDA and summary judgment? Please enlighten me. Anyone?