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Thanks for doing the research on this...we shall see!
Anyone know if the acquisition of IDT (integrated DNA technologies)back in 2018 by this company. Is this the same IDT company who VP Mike Pence just mentioned in the press conference as the company providing the Covid 19 test kits?
It doesn’t seem like the news that a deal was made with the feds has hit any of the major news outlets yet, just the one Bloomberg law news link posted on this board was all I can find. Thanks for the tip! It will be interesting to see what happens a when the rest of the world finds out!
They pioneered something that was spreading like wildfire and gaining momentum. Testimonials prove they were helping a tremendous amount of people, albeit harmed a few. Fact of the matter is no other company created such an easy affordable way to try cell therapy. They got the rug pulled out from them plain and simple, now to hear that the FDA is going to try to go after clinic by clinic which there are hundreds of and need to file individual lawsuits, IMO is a complete waste of govt resources and tax dollars. Oversees adipose studies have proven safety and efficacy, in time we should advance here as well.
And don’t forget the SEC charges dropping concurrent with the summary judgment win. I hope they highlight all this in that documentary KC is involved in.
Based on an Instagram post earlier in the year the clinics were getting products for for non -surgical therapies and diversifying their offerings in light of the lawsuit and its potential outcomes
https://www.instagram.com/p/BpXPOa6nJKZ/?igshid=1u2a6ez6o2qdg
Predictive Biotech’s wide variety of product offering’s including placenta & umbilical cord options detailed in link below
https://www.predictivebiotech.com/wp-content/uploads/2019/05/Product-Grid-for-Web_v2.pdf
Panic today and Rough day for the stock but the SEC investigation which started this whole panic in the beginning is over and no actions taken. That’s a big win which was hidden amongst the chaos
So let’s get this straight, record revenues released and within a day the PR on this SEC investigation which happened concurrent with Senator Grassley’s comments and the DOJ lawsuit. This took the stock from .07 to .02 back in April 2018, and was a year long investigation with no recommended actions?
Was this an “investigation” or an insurance policy in case USRM wins the lawsuit?
I am sure anyone who followed the timing and coordination of all of this have learned a lot here.
Both sides requested summary judgment however that doesn’t mean it will happen. Hence it being called a “request”. IMO a jury trial of peers would be ideal, however the longer this goes the more it costs. Therefore trying to get a win under summary judgment may be prudent here. I think it’s 50/50, I am not ignorant enough to say “there is no way” or “there is zero” chance. As that is just emotional bitterness and doesn’t make any sense. Every day more and more awareness is coming to these treatments and if either side doesn’t get the summary judgement in their favor, I am sure an appeal will be made and ultimately the jury of peers would happen.
This seems pretty compelling documenting that these guidance documents are guidance not law. I’m sure this will be highlighted over and over again !
Fake and Non-accredited are two different things....
The info and facts are below Happy Reading!
https://panamacollegeofcellscience.org/2019/01/23/kristin-comella-phd-leading-the-way-to-adult-stem-cell-therapy/
“This lawsuit followed closely on the heels of her blockbuster scientific report detailing the safety of adult stem cell therapy in 676 patients…the FIRST paper of its kind in the US. On peer review, this paper was not only passed without objection but was earmarked for immediate fast track publication in one of America’s most prestigious journals, the Journal of Clinical Medical Research.”
Read it for yourselves...Link here
https://stemcellcollege.files.wordpress.com/2017/10/safety-analysis-of-autologous-stem-cell-therapy-in-a-variety-of-degenerative-diseases-and-injuries-using-the-stromal-vascular-fraction.pdf
“The Panama College of Cell Science is a foreign institution, a division of Blue Marble University, registered in the Commonwealth of Dominica. The College continues to offer the ONLY doctoral program in stem cell biology in the world that can be taken online. The College is directed by Walter P. Drake, a published scientist with over 30 publications in bio-medical peer-reviewed journals. While not accredited in the US, where accreditation is not required whatsoever, the doctoral degrees issued by the Panama College of Cell Science are nonetheless equivalent to any doctoral degree issued by a regionally accredited US college or university.
What does “equivalent” mean? It means that our program is the SAME as any other program in terms of credits, and educational requirements. This is determined not by us, but rather by various foreign education evaluators. Every one of our graduates who has sought a certificate of equivalency to use our PhD for employment in the US or anywhere else has obtained such upon graduation.
Our program has even been pre-approved by the California University Foreign Credential Evaluation Service (CUFCE ) and the Certificate of Equivalency is shown below. When we sought review by CUFCE in 2011, the organization was on an approved list of foreign credential evaluators published by the United States Department of Education. The Department no longer maintains such a list, but now refers students to seek out a “professional foreign education evaluator” for such reviews. Nearly every foreign education credential evaluation service will find the same equivalency in our program.
Dr. Comella’s previous additional education includes a completed doctoral program in Chemical Engineering at Ohio State University where she passed her Comprehensive Examination for a Ph.D. degree but left to pursue her own research prior to completing her thesis. To better put her training into perspective: Her graduate studies and course work at Ohio State University provided her the opportunity to work with Dr. Jeffery Chalmers to focus on the use of nano-particles magnets to isolate/separate cells. She then delved more deeply into stem cell research at Osiris Therapeutics — a small start-up in Maryland — and was mentored within a company founded by the ‘father of Mesenchymal Stem Cells,’ Dr. Arnie Caplan. Following her work at Osiris, Dr. Comella was offered the opportunity to work with Dr. Darwin Prockop, the Grandfather of cellular therapy research on mesenchymal progenitors, at Tulane University.”
Nice to see Business as Usual! I personally don’t see this changing.
I like how the summary judgement is taking time. If this was such a slam dunk case like the FDA thought, the summary judgment would be quick IMO. Obviously this isn’t so black and white, and a lot of grey area exists here. Is the FDA losing their power and is less regulation going to prevail? Are more people thinking Big Pharma May have a monetary agenda? I really appreciate social media and what clarity it has provided throughout this process. Times may be changing!
Wrong again! If this was only about Kristen breaking the law why is it “Over the past 12 months, the FDA has sent “regulatory correspondence” to 45 clinics, according to The New York Times”???
This doesn’t seem like it is about only Kristen and some dirty vents in the lab nor a few blind ladies. This is clearly a systematic coordinated attempt to control these procedures nationwide IMO.
Considering the documented testimonials and lawsuits against clinics for adverse outcomes, it is as simple as this IMO.... the procedures seems to work for some and for others maybe it has zero effect and in a small number of cases there may be an adverse reaction or infetion. Not unlike a root canal, breast augmentation, nose job, or lasik eye surgery!
(Lasik eye surgery)
As an example, hundreds of thousands of people undergo Lasik surgery every year to improve their vision. This elective operation is only getting more popular, and some doctors refer to the procedure as one of the "safest medical procedures," as noted in this New York Times article.
‘That said, there are still people who experience complications as a result of Lasik. Some develop pain, dry eyes and visual aberrations that may or may not improve over time. However, these complications would likely not be the result of medical malpractice.”
When you perform tens of thousands of an medical procedure there is going to be variance in outcomes. There are so few adverse documented cases that I am all for people’s choice
MyCellsMyChoice!!!
Thanks for the post. Good info!
This is great!
‘I know what they’re trying to do and they’re not going to get away with it.”
I find it interesting how the NYTimes and Washington post both come out with articles on the same day highlighting different issues. Doesn’t seem coordinated at all LOL. Just like senator Grassley’s timing on demanding justice for the blind ladies just before another record breaking earnings report and stock price rising! So let’s get this straight....thousands of procedures annually yet two or three adverse events(not deaths)a year and it’s MAJOR news? Now the Washington post is bringing in Roger Stone and Trump? Is this for real? My goodness
Instagram post testimonial. “Thank you for my treatment before skiing. I was able to ski 4 days straight with no pain. Thank you US Stem Cell!”
Funny how success stories like this don’t make the NYTimes headlines however “several”, and when they say “several” they are referring to 3 patients, were blinded by stem cell treatment. Don’t mention when there is a life changing positive result!
Fact of the matter is if a grown up wants to spend 3-5k on a treatment to help them walk, ski, help psoriasis, eliminate pain, improve mobility, or whatever... let them try and see if it helps. It’s usually a last result after they have exhausted other options and feel helpless. Nothing is guaranteed and like any medical procedure there are risks and infections can occur. This is why waivers are signed and nothing is guaranteed.
NYT refers to 12 infections??? On how many tens of thousands of procedures? Cmon now! A lot of root canals get infected as well as breast augmentations, so why not stop these procedures as well?! Control issues and greed involved here IMO, don’t waste my time with these biased headlines and reports, I see through the BS.
Business as usual at the clinics and I don’t see this changing!
I agree, the argument of harming patients is bogus. Any medical procedure has risks and waivers are signed. the broken record of the 3 blind ladies being replayed over and over is ridiculous while 10,000 +procedures were performed and continue to be performed daily with no new adverse news. Nice to see in the UK the eye procure was effective and changed lives USRM is on the right track. They know it which is why they are fighting this and IMO will ultimately prevail.
New docs up on Pacer Monitor!
PROPOSED] ORDER
Pursuant to the parties’ Joint Motion for Exemption From Required Mediation Under Local Rule 16, filed on March 6, 2019, and for GOOD CAUSE shown, the Court hereby withdraws its referral of the parties to mediation because this case is not suitable for mediation.
DONE and ORDERED at Miami, Florida, this _____ DAY OF ___________, 2019.
Cc: All Counsel of Record
____________________________
URSULA UNGARO
UNITED STATES DISTRICT COURT JUDGE
Looks like Kristen is planning to speak March 22nd at this conference. IMO If mediation was going bad for USRM I don’t think she would be posting this speaking engagement on her Facebook.
https://regenerativeacademy.com/conference-2019arp/
Hard to argue this testimonial at an FDA public hearing requests for comments on the draft guidance for regulation of human cells
Interesting timing on this new flexibility from the FDA. Bring back MyoCell RMAT and while we’re at it the Hungry Hippo as well! Lol
The path wasn’t clear for Tomas and USRM to continue to spend money on the RMAT application. Is the path more clear now?
USRM has spent more than $100 million over two decades on both preclinical (animal) and clinical (human) trials using its MyoCell™ product. The trials published to date show culture-expanded autologous stem cells directly injected into the heart can provide benefit to congestive heart failure patients
(review full publication here: https://www.ncbi.nlm.nih.gov/pubmed/21982657)
Extremely foolish way to sell out when the 4 trades ahead of their 40k sell was 1/4 million in buys at the .025/.026 level. However I guess 40k in sells is less thank a grand anyway. Peanuts!
Looks like this is the FDA’s “expert” who USRM will take deposition of
https://www.fda.gov/AboutFDA/WorkingatFDA/FellowshipInternshipGraduateFacultyPrograms/CommissionersFellowshipProgram/ucm542702.htm
Kristen Comella has dedicated her career/life to regenerative medicine while Dr Yong’s previous employment was a lead scientific reviewer in plastic surgery????
“Prior to joining CBER/OCTGT in October of 2014, Carolyn was a Lead Scientific Reviewer in the Plastic and Reconstructive Surgery Devices Branches (PRSB) in the Division of Surgical Devices (DSD) in the Office of Device Evaluation (ODE) in the Center for Devices”
Just wait till the 10 million plus volume days come back!
Gotta hand it to Kristen and USRM for fighting. I would venture to guess at this point the DOJ would want to come up with an agreement in Mediation. IMO No way they want the press to get ahold of a jury trial on human cells being a “drug”. Keep in mind most people are not aware of the fight that is happening here. Looks to me like USRM and Kristen are winning, and if this does go to a jury trial this could explode and not to mention incredible exposure and awareness. Paradigm Shift in modern medicine folks.
Just getting beat up! Brutal
India developing stem cell transplant procedure for 155 million, goal to get this most advanced science out to the masses. Backed by govt funding and regulatory environment.
https://vimeo.com/287293609
Catalyst #1 earnings
Catalyst #2 update on SEC investigation potentially concluded? Haven’t heard anything on this in a while
Catalyst #3 mediation or jury trial!
Should be an exciting month around here.
Looking forward to the release of this film(link below)
Looks like these guys are prepared to fight for our right to stem cell therapy. Novartis is offering a recently approved FDA approved cell treatment for 500k. Is big pharmaceutical threatened by USRM’s 5k treatment?
https://vimeo.com/284441853
This isn’t a slam dunk for either side which is evident in the length of time this is and potentially will take to resolve. Much education and clarity is needed in order to make progress here. IMO the Stromal Vascular Fraction (SVF) adipose tissue for treatments/therapy hold a lot of promise due to abundant amount cells extracted through a non-invasive outpatient procedure. This almost seems too good to be true...One can liposuction fat, centrifuge the fat to isolate the stem cells, and then simply inject into the same patient? Most people have no clue what an SVF or Adipose tissue is, however there are thousands of clinics both domestic and international which are offering these therapies. Some of them like USRM are generating record breaking revenues. Treatments once only the rich could afford and travel outside of the country to get are now in a price range more people seem to be able to afford. What is the demand going to look like when “Adipose Tissue” and its benefits become well known?
Now the big question here is, does taking the fat tissue and processing it through centrifuge and enzymes warrant the adipose tissue for cells to be characterized as a “Drug” and in turn be under FSA regulation. The FDA has guidance documents which say their opinion is that these treatments should fall under the “drug” category however this is only guidance. The FDA director Gotlieb
Said himself we are in a “paradigm shift” in modern medicine with regenerative stem cell therapy, however it seems they want more control over this based on the recent lawsuit. Through mediation we may find out what is the fair approach here, otherwise it would go to trial of our peers. Ask yourself this....if you took random people off the street and asked them “should their own cells in their bodies be regulated by the FDA”. IMO the overwhelming response would be a big NO.
I think the DOJ/FDA realize if this goes to trial USRM’s chances of outright winning are extremely high. IMO the DOJ/FDA will take a “meet in the middle approach” in mediation to try and get some semblance of control/oversight. If not and USRM holds their ground, then good for USRM and people’s right to harness their own bodies to heal. I like their chances in a trial of peers. Downside here is 100% if USRM is shut down but there is infinite upside. Bottom line...if there was a legal way to shut them down it would have already happened, this is a control/oversight issue and one would be foolish to not think Big Pharma may be playing a role in holding these ground breaking therapies back as long as they can.
All just my opinion here folks
Good info here...
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5880231/
One would think that the management team and legal team have a good pulse on their chances with the upcoming mediation and possibly jury trial. USRM seems to be continuing to operate as “business as usual”.
This is the date I am waiting for.
ORDER Scheduling Mediation before Joseph P. Farina. Mediation Hearing set for 2/20/2019 09:00 AM
Anything agreed upon which isn’t a complete shutdown, coupled with consistent increasing revenues, awareness as well as procedure/product diversification is a step in the right direction. Once these outrageous legal fees are off the books imagine what the bottom line could look like. You can’t ignore the increasing revenues and popularity of these alternative treatments.
With this said, if there was going to be a complete shut down and jail time this would already have happened IMO. There
Is going to be some type of meet in the middle ground. Happy new year!
New instagram post.! All clinics now offering non-surgical therapy options through what looks like tissue product from Predictive Biotech. From what I read on Predictive’s website they believe sourcing tissue/adipose from young/healthy doners could be not only more consistent but more potent/effective.
More importantly it comes from an FDA registered lab, does this change the landscape with the current FDA concerns if USRM is using this product? IMO it would as the concern is how the adipose is being processed. I am excited to learn more but IMO what a great hedging strategy by USRM to offer tissue from another source and bypass the FDA’s processing concerns.
“By maintaining the integrity and quality of the tissue as it is harvested and transferred to the patient, we can better insure product viability. Our single-minded focus on minimizing tissue degradation shows in our careful procurement and minimal processing in our own FDA-registered lab. And it continues all the way to the doctor’s office where we provide custom cryotanks for maintaining product viability at a strict -196 degrees.
Criminal Charges LMAO! “FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA’s guidances means that something is suggested or recommended, but not required.”
Lucky for USRM The jury would be selected from a group of peers. Not experts or Big Pharma executives or State Senators. Instead real people who hopefully have common sense and are not pre-influenced. They will be told a story of stem cell advancement domestically versus other countries and over ten thousand procedures, countless success stories and very few SAE’s and of course the 4 blind ladies. How many people did Viagra blind again? Was it 5? USRM should be good to go then IMO, especially since this treatment isn’t mass distributed and put on shelves, instead it is an agreement between patient and doctor. Just my common sense opinion here.
To assume USRM will go BK and no plan is in place is foolish. They are generating a tremendous amount of revenue and have a solid legal team. Mediation may work in their favor but ultimately a trial would give this the exposure that would make this skyrocket! IMO we see a trial. They don’t seem to want to back down and if they don’t the trial is set, or the Other side may concede...time will tell.