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WFC$ Moving on up!
Everyday is one day closer to court decision.
USRM
All good points. Silent running until court decision is frustrating but I kind of expected it. I suppose things are in a holding pattern for now until court decision.
Just imagine the headlines for a positive USRM decision. It will be seen as a massive win beating the FDA even though the game isn't over. Optimism over the future of the stem cell business model will change.
I expect the 11th Circuit Court to RR this case. The CA case and Judge Bernal's decision to move forward with a trial - a case that mirrors USRM's to a "T" - cannot be ignored. The Appellate Court must be keenly aware of its significance. Bernal set a precedent by rejecting a summary judgment.
A favorable ruling moves things to the 4th quarter. I expect more dilution and silence after the run while we await the trial. I also see a new type of investor moving in...
Things will cool down until a decision. Up - down - flat - then ??? The good news in this scenario is that there will be a trial and another decision. The market likes knowing what is round the corner.
Dilution was inevitable considering the circumstances. Dilution won't inhibit a proper run up. A favorable court decision will move the game to the fourth quarter. Keep eye on ball.
USRM showing some strength. I find it interesting and unexpected. Waiting.
Another great day for WFC$. The Fed has 1.1T of liquidity they must find a place to park. Currently only 2 big banks have space on their balance sheets - BAC 150B and WFC 500B. WFC has much more room because of the Fed imposed asset cap which will need to be removed. It is no coincidence the Fed accepted WFC's remediation plan this week. Liquidity and gov fiscal stimulus along with an infrastructure bill will aid economic recovery which in turn will create an inflationary environment as the economy heats up. Tres. Sec. Yellen recently said she is not worried about inflation as a byproduct of adding more stimulus which is essentially acknowledging inflation is on the horizon. We are entering good times for the financial sector. Bullish 2021-2022.
The Fed, liquidity, needing a place to park 1.1T, and asset cap.
Good read as it relates to WFC's asset cap:
https://www.zerohedge.com/markets/here-we-go-again-zoltan-warns-repo-market-verge-major-shock-key-funding-rate-turns-negative?utm_campaign=&utm_content=Zerohedge%3A+The+Durden+Dispatch&utm_medium=email&utm_source=zh_newsletter
I think the cap will be removed soon.
Surprised this board is so quiet. Acceptance of the remediation plan is a major step forward in the asset cap removal process. An event like this is rare and historical considering the Fed had never before implemented this sort of harsh punishment. WFC has major upside potential.
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..:)
I agree. It would be a mistake to take the FDA lightly. The significance of the FDA's "authority" - as you stated - brings to mind that their authority is reliant upon having jurisdiction. It is my expectation that the judges will see that in this instance the FDA overreached itself as evidenced by their refusal to accept a double standard of their creation. As a result, the FDA's authority to determine what constitutes manipulated tissue is based on nothing more than self-serving ambiguity.
USRM
They harvest adult stem cells from adipose through a process called stromal vascular fraction (SVF) which separates stem cells from fat utilizing enzymes as a cutting (digesting) agent. You might want to read up on the FDA vs. USRM court case which is currently pending decision by the 11th Circuit Court of Appeals. Plenty on information including court documents for both sides available on this board.
The FDA pivoted away from their original argument claiming the SVF process creates a drug. They are now claiming SVF manipulates the tissue so that it is no longer the same tissue being replanted back into the same patient. The FDA states the tissue is no longer homologous (having the same relation, position, or structure). The FDA's argument is full of holes as it would also have to include any and all tissue transplantation procedures currently not under guidance of the FDA. The FDA has control over things like implants or surgical equipment, but they do not decide what is acceptable medical practice nor do they determine or tissue classifications.
I have a medial background and can elaborate, but I would suggest you do some DD on your own.
Exactly. I think other investors are beginning to look for opportunity stocks beaten down by the pandemic. I don't believe there is a cultural shift moving away from the cinema experience. Convenience and quality are separate measurables. I see the cinema market being disrupted not broken.
Very reasonable assessment. I agree. I bought into AMC because I see it as being a post pandemic >rebound< stock. There are a number of those out there. The question remains how high it will bounce? I'm patient.
It is not that simple to assume people won't go back to the theater. It is not practical to think the average person can recreate the theater experience at home. Once covid begins to retreat and more vaccinations occur there will be pent up demand to get back to normalcy and that includes experiencing life outside the house.
AMC's pre pandemic numbers are of less importance now imo. Humans are social beings. Isolation works against our natural desires. The irony in all this is that the pandemic may have taught us the importance of appreciating things we took for granted in the past. Going to the movies being one of them.
Yeah but I think I remember Ginsberg or some other judge saying that this was not the time to discuss damages. That may have been a precursor to their later decision to deny and punt it back to the lower court.
Yes. Thank you A1. The "bank cell" defense was not really on my radar. But the question still remains as to why it was brought up to the Court of Appeals in the first place? Waste of time.
This >
BSTN must be in the fishing business now. Looking to hook their next victim. Where is Bertsos? Is he swimming with the fishes where he belongs?
No thanks!
Financing studies and FDA approval for equipment/instrumentation related to stem cell procedures is secondary right now. The implications of the Court of Appeals case is priority. Initially, USRM would benefit from a favorable ruling because they are already in the market place and are a publicly traded business. If the court were to side with USRM this could open the door for stem cell treatments to be regulated by state and local medical boards.
The ruling (either way) will impact medicine on a national level. If USRM wins their appeal, the FDA would have no oversight as is the case with any autologous tissue transplant procedure done today. A company like USRM would only need to apply for a business license to operate. Any devices used to harvest stem cells would come under FDA control. But the tissue itself (SVF harvested stem cells) would not. The main argument of the FDA is full of holes and I would suggest anyone interested in this case read both sides of the argument to fully understand the dispute.
Almost $11 K dollar volume? I thought this company was sunk? What's up?
$10 K volume? I thought this company was sunk? What's up?
That could be true. Optimism is fine. But I'm not sure partnerships matter unless there is a favorable court ruling for USRM. We are at the mercy of judges who have no training in microbiology or medicine. With that said, I don't believe it takes a scientist to see through the FDA's argument.
Would be great if this closes around $10.
USRM Appellate Court decision: What publicly traded company in the stem cell sector has the same transformational catalyst on deck?
The pending court decision (opinion) is "the" only reason I am here.
Good summary. Thank you.
Patience...USRM$
Buckle up! AMC$
Great read. Thanks.
Stay strong AMC$
This is hilarious. AMC$
I would be shocked if a court ruling came today or tomorrow or next week. This is a major decision with huge implications. A decision will come, but deliberation takes time. It is a part of due process. I expect the 11th Circuit Court of Appeals is monitoring this closely.
A quick decision may not be in our best interests by a lower court...
Thank you for posting the link.
https://rickjaffeesq.com/2021/01/24/for-the-same-surgical-procedure-autologous-stem-cell-transplant-crowd-big-decisions-are-a-coming/
I find this interesting:
"Well folks, on Tuesday, January 26, 2021, the FDA’s injunction trial will start against Cell Surgical Network will begin. All the pre-trial paperwork has been on file for many months. It seems like the trial will take place by Zoom, but that’s more of an assumption on my part since I have not seen anything official about that in the docket. Since the paperwork is already on file (including the parties’ proposed findings of fact and conclusions of law), and because the judge has already ruled on the core issue, I wouldn’t expect him to take too long to issue his decision. I would say inside of 30 days, maybe 45 at the latest."
And this:
"There is another factor that might propel the judge to issue a quick decision, namely the fact that the Eleventh Circuit Court of Appeals will be issuing its decision on the US stem cell case in the next couple of months. District Judge Bernal may want to give his views on this core issue before the appellate court does and might prefer that the appellate court reacts to his decision, rather than the other way around, given the fact that his is the “inferior” court."
I am starting to feel optimistic about the outcome... :)
The opinions of the judges will be based on their interpretations of law and how it applies to the facts of the case as presented.
These are some important facts in this case as I see them to be:
Fact - The FDA has determined that SVF harvested stem cells are drugs because the tissue is not the same as it was after SSP transplantation.
Fact - The FDA refuses to see the same circumstances apply to ALL harvested autologous transplantation SSP's which the FDA has no control.
Fact - The FDA created a non scientific based double standard singling out harvested SVF stem cells as being drugs.
Fact - The FDA is not disputing stem cells are altered by the SVF procedure, but rather the process of separating the stem cells somehow magically creates a drug out of natural tissue.
Fact - The FDA is contradicting itself through their application of rules based on convenience rather than science.
My opinion - The FDA overstepped its jurisdiction by singling out harvested stem cells as being different than other tissue making FDA guidance as it applies to harvesting of stem cells inconsistent. The FDA is not acting in the best interest of the public.
These facts the judges cannot ignore.
Insightful post D.L. The FDA argument is full of holes. But will the appellate justices see the obvious? Could they be waiting for a ruling in the CA case before posting their opinion?
If "I" were a justice on the appellate court, I would want to see what transpires in the CA case before passing judgement. If it were the other-way-round, we might have seen the CA case rescheduled for a later date...but that hasn't happened.
I expect the courts to be focused mostly on determining disputes surrounding terminologies, classifications, and guidance. Yet these same judges cannot be ignorant to the swing in public opinion towards needing (not wanting) RTT and self determination. Unlike experimental drug therapies, the real question surrounding stem cell treatments focuses more on effectiveness as opposed to bodily harm. When we look at the role of the FDA as protectors of the people, our legal system must respect the need for people to determine what is best for themselves through knowledge gained from patient-provider consultation.
Good post. I agree that it is better for Tomas (USRM) to lay low until a decision has been made. When a judge says the banked cell will not be destroyed that tells (me) he does NOT view them as drugs; instead, he sees them as personal property. Why then would this case be sent back down for trial? I see no reason.
"Wonder how long it will take ?" Hey sor92 ole timer. How you doin'?
I wish I knew..lol. I have a hunch, but I am going to stay away from predictions as this can be a slippery slope. I planted a seed long ago and then waited for the legal battle to conclude. I think we are almost there.
I don't see this situation being like RMAT, or merger talk, or some fluffy rumor mill. This is black and white. It will conclude. And in the end it will be transformative either way.
Written final ruling by 11th Circuit Appellate Court
Link: https://www.ca11.uscourts.gov/opinions
We watch and wait.
I suppose it is possible that the case against USRM could get dismissed. No need for lower court trial. The more I think about it, the more I believe the ruling could very well be as you stated below...
"2) Or, OVER TURN IT COMPLETELY and hand a WIN TO USRM, as in 100% CASE CLOSED w/ "FDA YOU HAVE NO CASE" or standing here."
It seems as though that one judge tipped his hand for all to see at least with the stem cell banking case. If he does >not< believe SVF adipose harvested stem cells are a drug (an adulterated drug) then the only logical conclusion would be the stem cells are to be considered as a part of native (autologous) tissue. Case closed. FDA overstepped their bounds.