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More young adults in the US are dying from heart failure
https://www.cnbc.com/2019/05/06/more-young-adults-in-the-us-are-dying-from-heart-failure-study-finds.html
Thank you for the clarification.. $AXSM
Axsome Therapeutics Announces Expedited Development and Pivotal Status for AXS-05 in the Treatment of Major Depressive Disorder based on FDA Breakthrough Therapy Meeting
https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-announces-expedited-development-and-pivotal?field_nir_news_date_value[min]=2019
https://www.nasdaq.com/press-release/axsome-therapeutics-announces-expedited-development-and-pivotal-status-for-axs05-in-the-treatment-20190506-00151
Major Depressive Disorder. STRIDE-1 trial of AXS-05 for TRD
https://axsome.com/disease-states/treatment-resistant-depression-trd/
https://www.clinicaltrials.gov/ct2/show/NCT02741791
Pluripotency or differentiation? That is the question
https://www.sciencedaily.com/releases/2019/05/190502143412.htm
$AXSM 18.48 +.53
Based on the faster-than-expected enrollment in this trial, topline results are now expected in the second half of 2019, versus previous guidance of the first quarter of 2020
Axsome Therapeutics Announces Acceleration Of MOMENTUM Phase 3 Trial Of AXS-07 In Migraine
https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-announces-acceleration-momentum-phase-3?field_nir_news_date_value[min]=2019
Welding with stem cells for next-generation surgical glues
New generation of smart surgical glues and dressings for chronic wounds
https://www.sciencedaily.com/releases/2019/04/190423133727.htm
Thanks for the updates.. Impressive resume.. $USRM
$CLSK 2.39 HOD
FDA Approved.. Stem cells are non addictive and proven to give relief (Not Approved by the FDA) . Thanks for sharing.. $USRM
US Stem Cell Litigation Goes to the Court for Decision
April 4, 2019 Richard Jaffe
Per Pacer, on April fools day (with whatever significance that has to you), both sides submitted their replies on their respective summary judgement motions. The case is now as lawyers say, sub judice, (submitted for and pending decision).
No big surprises in these last papers. The government says the defendants are violating FDA laws and regulations, based on the FDA’s interpretation of the FDA statutes, and that the defendants admit the violations. The defendants argue that they are not subject to FDA drug requirements because the law doesn’t apply to them because it’s the practice of medicine and it’s a same day exempt surgicial procedure under 21 CFR. 1271.15.
The papers filed on both sides are excellent. The arguments were clearly made, and professionally and forcefully highlight the differences between the parties’ position.
I don’t think there was any more to be said on behalf of the defendants.
High quality papers like these help the judge make a decision, and I’m sure are appreciated by the court. So, congrats to both sides for a job well-done.
Look to a decision by late April.
Still, I don’t think that a Government win will have the effect the FDA or the anti-private stem cell clinic folks are hoping for. The industry has already, or is in the final process of moving on to the next HCT/P’s, and some of these puppies are likely to be harder for the FDA to stop under the current regulations and guidance documents. And, even if not, the whole process is going to have to start over again, the outcry from the stem cell establishment, inspections, delays, warnings letters, lawsuits. My prediction is that we will be well into the mid-2020’s before we’re at the same point with the next batch of products, at least if the FDA follows its current game plan. That’s going to make some folks happy, and others, not so much.
Rick Jaffe, Esq.
rickjaffeesquire@gmail.com
http://rickjaffeesq.com/2019/04/04/extra-extra-us-stem-cell-litigation-goes-to-the-court-for-decision/
A new way of licensing adult stem cell clinics should be considered. Actually at this time, there is no licensing pathway. And why? Because in what would appear to be a power grab, the United States Food and Drug Administration (FDA) has declared living cells in our bodies to be “drugs”.
How is a living cell that breathes oxygen, “talks” to adjoining cells via messenger molecules, reproduces itself and eventually dies a “drug”. Only in America…
The FDA has no jurisdiction over the stem cells in my body, and if i want to collect them from my abdomen, concentrate them and put them somewhere else, this is a Medical Procedure between me and my physician, not anything about drugs. A Medical Procedure. Same as when an immunologist injects a patient with mold, cat hair, pollen, house dust and other material in a a process called allergy shots. Is the mold, dirt, cat hair and other foreign substances that the immunologist injects into a patient regulated by the FDA? No. Why? Because these are medical procedures under the control of the physician even though unnatural, foreign materials are injected into a patient. Does every immunologist use the same ingredients? No. Each physician may collect different molds, dirt, cat hair and so forth from the individual patient’s surroundings. Yet, the use of these unregulated injectable substances is permitted by the FDA.
Should Embryonic stem cell preparations be regulated? For sure, because they always cause tumors or are immediately recognized as foreign to the patient’s body and are rejected. The hope and purpose in creating embryonic stem cell preparations is that a physician can use a patented off the shelf product to treat some condition. We say “hope”, because after over 20 years of study there has yet to be one single preparation created that can treat a disease or condition.
Compared to Adult Stem Cell therapy, which has been treating patients’ diseases and conditions successfully for over 20 years worldwide.
It is time for American politicians and people in power to wake up and get serious about exploring this new medical modality.
Adult Stem Cell therapy should be regulated by State Medical Boards, just like outpatient surgery centers are. Therapy using adult stem cells is so much closer to outpatient general surgery than it is to dispensing a “drug”.
No national regulation is required provided the States take control. But as long as the FDA sits there like a big elephant on the railroad tracks, nothing moves forward and the American people are deprived of this great new medical advance that our best scientists and practitoners should be developing.
Thailand recognized that their FDA, which essentially is the same as ours, was not the appropriate regulator for stem cell medical procedures. Stem Cell Treatment centers in Thailand are regulated and licensed by a special Medical Board composed of practicing physicians who decide about proper procedures and handling of a patient’s stem cell collected from blood, bone marrow, or fatty tissue.
It’s a good example to follow. And even though Thailand offers a robust stem cell health care, there has yet to be any complaint or bad result from adult stem cell transplants using the patient’s own stem cells since their special Medical Board was created about 12 years ago.
This is what the US should implement.
We say again, the treatment of patients with adult stem cells is closer to an outpatient surgery procedure than to the dispensing of drugs.
https://panamacollegeofcellscience.org/2019/03/17/stem-cell-clinics-should-be-regulated-by-medical-boards-not-the-fda/
Solving Cannabis’ Energy Problem
https://ih.advfn.com/stock-market/USOTC/cleanspark-inc-CLSK/stock-news/79821000/solving-cannabis-energy-problem
Regal Consulting, LLC working hard...
Legal Disclaimer:
This article was written by Regal Consulting, LLC (“Regal Consulting”). Regal Consulting has agreed to a three-month term consulting agreement with CLSK dated 9/12/18. The agreement calls for $10,000 in cash, and 30,000 restricted 144 shares of CLSK per month. Regal and CLSK have signed an amendment to extend the contract for twelve months starting 10/10/18, and increased the cash component to $20,000 per month. CLSK has paid an additional $12,000 for services provided in November. CLSK has paid an additional $88,000 for services provided in December. CLSK has paid an additional $100,000 for services for January. CLSK has paid an additional $100,000 for services for February. Regal was paid an additional $100,000 for March services. CLSK has paid an additional $100,000 for services for March. CLSK has paid an additional $80,000 for services for April. CLSK has paid All payments were made directly by Clean Spark, Inc. to Regal Consulting, LLC. to provide investor relations services, of which this article is a part of. Regal Consulting also paid one thousand dollars cash to microcapspeculators.com to distribute this article. Regal Consulting may have a position in the securities mentioned in this article at the time of publication, and may increase or decrease its position without notice. This article is based on public information and the opinions of Regal Consulting. CLSK was given an opportunity to edit this article. This article contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any results predicted herein. Regal Consulting is not registered with any financial or securities regulatory authority, and does not provide or claim to provide investment advice.
Specialized plant cells regain stem-cell features to heal wounds
https://phys.org/news/2019-05-specialized-cells-regain-stem-cell-features.html
Anyone know why the Unrestricted and Restricted shares are Not Available?
Need to call the Transfer Agent
VStock Transfer LLC
18 Lafayette Place
Woodmere, NY 11598
212-828-8436
www.vstocktransfer.com
https://www.otcmarkets.com/stock/CELZ/security
Earnings, Thursday Morning, May 9
Why Do Americans Take So Many Prescription Drugs?
https://www.oftwominds.com/journal08/Prescription-Drugs.htm
Dr. Comella is a pioneer for the stem cell industry.. $USRM
$BTCY $0.751 -.074 Volume 31,747
Mixed Cell Regenerative Medicine and the 21st Century Cures Act: The Law Authorizing Adult Stem Cell Therapy in the United States
https://panamacollegeofcellscience.org/2019/03/27/mixed-cell-regenerative-medicine-and-the-21st-century-cures-act-the-law-authorizing-adult-stem-cell-therapy-in-the-united-states/
Stem Cell Clinics Should Be Regulated by Medical Boards, Not the FDA
https://panamacollegeofcellscience.org/2019/03/17/stem-cell-clinics-should-be-regulated-by-medical-boards-not-the-fda/
Good read.. Thanks.. $USRM
Capicua regulates neural stem cell proliferation and lineage specification through control of Ets factors
https://www.nature.com/articles/s41467-019-09949-6
Forget sperm and eggs, researchers have created embryo stem cells from skin cells
https://phys.org/news/2019-05-sperm-eggs-embryo-stem-cells.html
$CLSK $2.10
Nation's first stem cell collection center opens in Palm Beach County
https://www.wpbf.com/article/nations-first-stem-cell-collection-center-opens-in-palm-beach-county/27326784
Capicua regulates neural stem cell proliferation and lineage specification through control of Ets factors
https://www.nature.com/articles/s41467-019-09949-6
A company to watch in the space is CleanSpark, Inc. (USOTC: CLSK), a microgrid company with several revenue generating projects. It released an Edgar filing reporting $20 million in financing in the form of Debenture, the Series B Preferred Stock, the Warrant and the Common Stock. With the warrants being priced $3.50 per share with respect to 2,000,000 Warrant Shares, $4.00 with respect to 100,000 Warrant Shares, $5.00 with respect to 100,000 Warrant Shares, $7.50 with respect to 50,000 Warrant Shares and $10.00 with respect to 50,000 Warrant Shares, the parties are surely anticipating growth. This committed financing will help accelerate the development and deployment of CleanSpark's Distributed Energy Resource (DER) Solutions to commercial customers.
CLSK has outlined several initiatives in their recent letter to shareholders. CLSK is planning to initiate a marketing campaign to start reaching indoor cannabis growers dealing with inefficient energy usage in need of their services, push forward their projects with recent acquisition of Intellectual Property of Pioneer Critical Power Inc, and facilitate growth in their R&D to find new industries their solution can improve. Start your research now.
Legal Disclaimer:
This article was written by Regal Consulting, LLC (“Regal Consulting”). Regal Consulting has agreed to a three-month term consulting agreement with CLSK dated 9/12/18. The agreement calls for $10,000 in cash, and 30,000 restricted 144 shares of CLSK per month. Regal and CLSK have signed an amendment to extend the contract for twelve months starting 10/10/18, and increased the cash component to $20,000 per month. CLSK has paid an additional $12,000 for services provided in November. CLSK has paid an additional $88,000 for services provided in December. CLSK has paid an additional $100,000 for services for January. CLSK has paid an additional $100,000 for services for February. Regal was paid an additional $100,000 for March services. CLSK has paid an additional $100,000 for services for March. CLSK has paid an additional $80,000 for services for April. CLSK has paid All payments were made directly by Clean Spark, Inc. to Regal Consulting, LLC. to provide investor relations services, of which this article is a part of. Regal Consulting also paid one thousand dollars cash to microcapspeculators.com to distribute this article. Regal Consulting may have a position in the securities mentioned in this article at the time of publication, and may increase or decrease its position without notice. This article is based on public information and the opinions of Regal Consulting. CLSK was given an opportunity to edit this article. This article contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any results predicted herein. Regal Consulting is not registered with any financial or securities regulatory authority, and does not provide or claim to provide investment advice.
https://ih.advfn.com/stock-market/USOTC/cleanspark-inc-CLSK/stock-news/79808541/clean-energy-investments-to-watch
Thank you.. $USRM
FDA can't stop PROGRESS.. Americans' interest in stem cell therapy continues to grow.. $USRM
Dr. Comella explained how the FDA ignored testimonies from adult stem cell practitioners during their 2015 public hearings regarding new guideline proposals. Then they arranged to create new rules behind closed door meetings that included pharmaceutical industry allies and insiders.
http://healthimpactnews.com/2019/fda-wants-to-shut-down-adult-stem-cell-therapy-as-its-healing-powers-are-experienced-around-the-world/
Systemic Corruption at FDA Reported
https://anh-usa.org/systemic-corruption-at-fda-reported/
A loss in court could undermine the FDA's ability to regulate the industry.. $USRM ..Case Dismissed
AUA Annual Meeting May 3-6 2019, Chicago
http://www.aua2019.org/
1st quarter earnings, Thursday, May 9, 2019
Umbilical cord-derived mesenchymal stem cell extracts ameliorate atopic dermatitis in mice by reducing the T cell responses
https://www.nature.com/articles/s41598-019-42964-7
Outstanding Shares 393,694,820 +379,141 04/26/2019
Restricted 80,461,475 (0)
Unrestricted 313,233,345 (o)
Pharmaceutical companies want to sell you their modified stem cells.. Very informative.. Thanks for sharing.. $USRM
WARNING This company is in chapter 7 bankruptcy!