US Stem Cell Inc (USRM)

[sdave2002]

QUOTE LOL, Hippo DD info found here!

Must read info submitted by board admin HHippo

Plenty of material here with links... Enjoy!

1. WHAT IS MYOCELL?

ABOUT MYOCELL(R) CLINICAL CELL THERAPY:

MyoCell(R) clinical cell therapy is intended to be used to improve cardiac
function months or even years after a patient has suffered severe heart damage
due to a heart attack. The procedure involves a physician removing a small
amount of muscle obtained from the patient's thigh. From this muscle
specimen, autologous myoblasts (muscle stem cells) are then isolated, grown
using Bioheart's proprietary cell-culturing process, and injected directly
into the scar tissue of the patient's heart. The myoblast cells are delivered
via an endoventricular needle-injection catheter during a minimally invasive
procedure performed by an interventional cardiologist or vascular surgeon.
The myoblast-based muscle formation in the newly populated regions of scar
tissue are intended to improve cardiac function by helping the heart muscle
beat more efficiently.

b]MyoCell, a cell-based, autologous skeletal myoblast therapy for the treatment of cardiovascular diseases

MyoCell, autologous SkMs delivered by MyoCath and MyoStar catheter delivery systems for the treatment of cardiovascular diseases such as myocardial infarction and congestive heart failure. MyoCell is undergoing phase II/III clinical development and has so far demonstrated safety and efficacy, including improvements in cardiac function in phase I/II clinical trials.

bone marrow-derived stem cells and skeletal myoblasts (SkMs; muscle progenitors that can undergo mitosis and differentiate into mature muscle) are the best studied in experimental animal models and clinical trials. Numerous studies have examined their potential therapeutic effects on myocardial function and regeneration [952205], [952210], [952212], [952213]. While many of these studies have added to the mounting evidence for extensive myocardial regeneration [951506], [951973], some have shown poor or even no differentiation of bone marrow stem cells into cardiomyocytes [952214], [952217]. SkMs have many advantages over other cell types, including availability without ethical issues, ease of in vitro expansion to large numbers without loss of differentiation potential, increased resistance to ischemia and inherent myogenic ability. In addition, transplantation of autologous SkMs eliminates the risk of cell graft rejection without the use of immunosuppressants.

MyoCell, being developed by Bioheart Inc, uses autologous skeletal muscle-derived stem cells for engraftment into the infarcted heart [745596] and represents a leap forward in stem cell technology. After nearly two decades of intense research, MyoCell is being investigated for the treatment of MI and congestive heart disease and is currently in phase II/III clinical development [872586], [954700]. Moreover, the use of MyoCath and MyoStar catheter systems, an autologous SkM delivery system from Biologics Delivery Systems Group, Cordis Corporation, allows target-specific delivery of autologous SkMs into the infarcted myocardium [745596].

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2668534/

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2. THE FDA IS CONSIDERING REGENERATIVE MEDICINE ADVANCED THERAPY DESIGNATION FOR MYOCELL.

ANALYZE STATEMENTS FROM THE LAST 4 BLOGS:

"April Blog"

On January 27, 2017, U.S. Stem Cell, Inc. applied for the FDA’s new Regenerative Medicine Advanced Therapy (RMAT) designation for the MyoCell™ product as part of the MARVEL trial. After application, the FDA is given 60 days to review it or request additional information. In late March, the FDA requested additional information in order to reinstate our IND (MARVEL trial)—which has been reinstated to active status. Please note that each time more information is requested, the 60-day timeline resets and the FDA is afforded additional regulatory processing time.

OK SO LATE MARCH THE CLOCK RESET.

60 DAYS FROM LATE MARCH PUTS US AT LATE MAY. THIS TIME HAS PASSED. SO...


THE FIRST CLOCK RESET HAPPENED IN MARCH 2017 as referenced in this May Blog:

At the beginning of the year, we applied for the FDA’s new Regenerative Medicine Advanced Therapy (RMAT) designation for our MyoCell™ product. In March 2017, the FDA reinstated our IND (MARVEL trial) to active status. In May, the FDA acknowledged that they received our additional information and are still in the process of reviewing our application for RMAT. Please note the FDA takes up to 60 days to review information submitted.

AT THE TIME OF THE MAY 31ST BLOG OUR NEW INFORMATION HAD ALREADY BEEN SUBMITTED.

NOW THE JUNE BLOG THAT MADE EVERYONE LOSE THEIR MIND:

"June off to an amazing start"

As many of you know, we have been working with the FDA regarding Regenerative Medicine Advanced Therapy (RMAT) designation for our MyoCell™ product. The RMAT process with the FDA has been quite cumbersome, time consuming and interactive as each request for additional information restarts the FDA’s 60-day clock—and the clock again restarting when we provided additional input on the $100,000,000 in clinical research we have invested on Myocell research thus far. As a small company with limited resources, this process has proven unsustainable until the FDA determines an equitable path for all companies applying—which is apparently not the case today. Even if approved for RMAT, we are still uncertain as to what the designation would mean for our company nor how we could benefit our patients in need. U.S. Stem Cell cannot afford to continue this undetermined path so at this time, we have decided not to further invest funds in pursuing RMAT Designation and instead focus on our in-clinic therapies for patients.


WHAT DOES THIS SAY?

TO ME IT SAYS:
-THAT NO DECISION HAS BEEN MADE YET.
-THE CLOCK HAS BEEN RESET SINCE THE LAST TIME INFORMATION WAS GIVEN &
IN MY OPINION FROM THESE STATEMENTS AND TIMELINES WE CAN ASSUME THAT IN LATE MAY, USRM RECEIVED A REQUEST FOR MORE INFORMATION AND DELIVERED IT PROMPTLY TO THE FDA.

THEREFORE THE NEW TIME LINE TO EXPECT RMAT DECISION WILL BE JUST BEFORE JULY 31ST IN MY OPINION.

THAT IS APPROXIMATELY 27 TRADING DAYS.
SO IF YOU WANNA DUMP YOUR SHARES B/C YOU CANT WAIT. GO RIGHT AHEAD BECAUSE I KNOW MANY LONGS THAT HAVE ALREADY WAITED MUCH LONGER THAN THAT.

US Stem Cell has been in discussions with the FDA regarding Regenerative Medicine Advanced Therapy (RMAT) Designation for the Myocell product and at this time, the company has decided not to further invest in RMAT Designation and instead invest and focus on our in-clinic therapies for patients.

THIS DOESNT MEAN THAT WE HAVE WITHDRAWN OUR APPLICATION OR "GIVEN UP" ON ANYTHING.

According to the 21st Century Cures Act, within one year of enactment, the FDA must issue draft guidance clarifying how the FDA will evaluate devices used in the recovery, isolation, or delivery of regenerative advanced therapies. Until this guidance document is published, it is unclear how this regulation will affect the MyoCell program.


From CSO Comella Blog:

As many of you know, we have been working very closely with the FDA to understand the new Regenerative Medicine Advanced Therapy (RMAT) designation. As with many regulations, the process can be cumbersome and difficult to navigate. At this time, the FDA has not defined what RMAT designation will mean and as a result, it is unclear how this new regulation will help our company or technology.

UNCLEAR. WHY? WHY IS IT UNCLEAR? DOESN'T HELP ACHIEVE THE GOAL OF GETTING REGENERATIVE MEDICINE TO THE PUBLIC. WELL AFTER ANALYZING, I WOULD HAVE TO AGREE.

BECAUSE=

NUMBER 1- THERE WERE ALREADY EXPEDITED PROGRAMS FOR SERIOUS CONDITIONS.

EXPEDITED PROGRAMS THAT ALREADY HAVE GUIDANCE.

RMAT DOES NOT HAVE GUIDANCE YET. BECAUSE IT IS A NEW PROGRAM.

HERE IS THE GUIDANCE FOR THE OTHER 4 PROGRAMS.

You've heard of them: They are;



Guidance for Industry
Expedited Programs for Serious Conditions – Drugs and Biologics

https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf

YOU SEE THOSE 4 PROGRAMS ACTUALLY HAVE GUIDANCE AND PURPOSE.

NUMBER 2 REASON - THIS IS ALL THE FDA HAS GIVEN US CONCERNING RMAT:

https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm537670.htm

As described in Section 3033 of the 21st Century Cures Act, a drug is eligible for regenerative medicine advanced therapy (RMAT) designation if:

The drug is a regenerative medicine therapy, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, except for those regulated solely under Section 361 of the Public Health Service Act and part 1271 of Title 21, Code of Federal Regulations;

The drug is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and Preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition

THEY TELL YOU WHAT RMAT IS. THEY DON'T TELL YOU WHAT IT MEANS.

THERE IS NO GUIDANCE YET.

COMELLA AND TOMAS ARE RIGHT IN MY OPINION.

DOES MYOCELL QUALIFY FOR RMAT?

THE COMPANY BELIEVES IT DOES. AND SO DO I.

MYOCELL:

IS IT AN UNMET MEDICAL NEED? I THINK SO. (THERE IS NO OTHER TREATMENT FOR POST HEART ATTACK SCAR TISSUE REPAIR)

IS IT A SERIOUS OR LIFE-THREATENING DISEASE OR CONDITION? I THINK SO.

FDA DEFINITION:

A. Serious Condition

1. Whether a Condition Is Serious

FDA intends to interpret the term serious as it has done in the past for the purposes of accelerated approval and expanded access to investigational drugs for treatment use. A serious disease or condition is defined in the expanded access regulations as follows:

. . . a disease or condition associated with morbidity that has substantial impact on day-to-day functioning. Short-lived and self- limiting morbidity will usually not be sufficient, but the morbidity need not be irreversible if it is persistent or recurrent. Whether a disease or condition is serious is a matter of clinical judgment, based on its impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one.

IS MYOCELL INTENDED TO TREAT A SERIOUS CONDITION?

Whether the Drug Is Intended to Treat a Serious Condition
As referenced in section IV, the statutory and regulatory eligibility criteria for expedited programs require that a drug be intended to treat a serious condition. To satisfy this criterion, a drug must be intended to have an effect on a serious condition or a serious aspect of a condition, such as a direct effect on a serious manifestation or symptom of a condition or other intended effects, including the following:

• A diagnostic product intended to improve diagnosis or detection of a serious condition in a way that would lead to improved outcomes
• A product intended to mitigate or prevent a serious treatment-related side effect (e.g., serious infections in patients receiving immunosuppressive therapy)
• A product intended to avoid or diminish a serious adverse event associated with available therapy for a serious condition (e.g., product that is less cardiotoxic than available cancer therapy)8
• A product intended to prevent a serious condition or reduce the likelihood that the condition will progress to a more serious condition or a more advanced stage of disease

DOES MYOCELL MEET AN UNMET MEDICAL NEED?

FDA DEFINES AN UNMET MEDICAL NEED:

Unmet Medical Need:
An unmet medical need is a condition whose treatment or diagnosis is not addressed adequately by available therapy. An unmet medical need includes an immediate need for a defined population (i.e., to treat a serious condition with no or limited treatment) or a longer-term need for society (e.g., to address the development of resistance to antibacterial drugs).

Where There Is No Available Therapy
If there is no available therapy for a serious condition, there is clearly an unmet medical need.

SO WE KNOW THAT WE ARE POTENTIALLY QUALIFIED FOR RMAT.

HOW ARE WE GOING TO GET MYOCELL TO THE TERMINALLY ILL PATIENTS WITH CHRONIC AND ADVANCED HEART DISEASE ESPECIALLY WHEN THERE IS SO MUCH RED TAPE AT THE FDA?AND WE DONT EVEN KNOW WHAT RMAT WILL DO FOR US UNTIL GUIDANCE IS ISSUED.

ANSWER: THE LAW. ITS TRANSFORMING BEFORE OUR VERY EYES.

Many Americans facing terminal illness are not so fortunate. Under the normal FDA process, terminally ill patients who do not qualify for a clinical trial and want to try an investigational medication must, with their physician's permission and the approval of the pharmaceutical company, undergo a lengthy application process with the FDA. Patients can typically only receive drugs where there is evidence that shows the drug is reasonably safe. The FDA estimates that the application alone takes 100 hours of a physician's time to complete, although the agency has promised a more streamlined process.

http://www.heart.org/HEARTORG/Conditions/HeartFailure/Advanced-Heart-Failure_UCM_441925_Article.jsp#.WUncNTOZNgc

The Code of Laws of the United States of America (variously abbreviated to Code of Laws of the United States, United States Code, U.S. Code, or U.S.C.) is the official compilation and codification of the general and permanent federal statutes of the United States.

According to 26 USCS § 101(4)(A), the term "terminally ill individual" means an individual who has been certified by a physician as having an illness or physical condition which can reasonably be expected to result in death in 24 months or less after the date of the certification.

https://www.law.cornell.edu/uscode/text/26/101

SO. DOES MYOCELL QUALIFY TO TREAT TERMINALLY ILL PATIENTS?

THERE ARE 4 STAGES OF HEART FAILURE.

Stages
There are four different stages of heart failure. These stages range from being at a high risk for this condition to being in the end stage. The stages include:

Stage 1 (A): The patient does not yet have a heart structural disorder, but is at a very high risk of developing this disease. Those in this stage have a high risk due to having coronary artery disease, a history of abusing alcohol or drugs, a family history of cardiomyopathy, high blood pressure, diabetes, or a history of rheumatic fever. Other medical conditions, and lifestyle and environmental factors, can also put a person at a high risk.

Stage 2 (B): During this stage, the patient has not developed symptoms yet, but they have a structural disorder. Examples include having a structural heart disease, such as heart fibrosis, previous heart attack, left heart enlargement, or valve disease.

Stage 3 (C): During this stage, the patient has underlying structural heart disease and current or past symptoms of this condition.

Stage 4 (D): During this stage, also referred to as the end-stage, patients are often hospitalized and will require special treatments, such as an artificial heart, heart transplant, LVAD, inotropic infusions, or hospice care.

- See more at: http://www.healthguideinfo.com/congestive-heart-failure/p85375/#sthash.TzN3353R.dpuf

HOW LONG CAN YOU LIVE WHILE IN STAGE 4 (D)?

While advancements have been made, 50% of patients will have an average life expectancy of five years. For those with advanced heart failure, up to 90% will pass away within one year. When asking how long can you live with congestive heart failure, those at a moderate stage will average ten years.

THAT MEANS ADVANCED HEART FAILURE ABSOLUTELY FALLS UNDER THE DEFINITION OF "TERMINAL."

About Congestive Heart Failure

Congestive heart failure, or CHF, is a debilitating condition that occurs as the heart becomes progressively less able to pump an adequate supply of blood throughout the body resulting in fluid accumulation in the lungs, kidneys and other body tissues. Persons suffering from NYHA Class II or worse heart failure experience high rates of mortality, frequent hospitalization and poor quality of life. Although medical therapy for CHF is improving, it remains a major debilitating condition. According to the American Heart Association Heart Disease Statistics – 2007 Update, the estimated, total direct and indirect costs of heart failure in the United States in 2006 were approximately $33.2 billion. The AHA also estimates there to be over 5 million heart failure patients in the U.S. and an additional 500,000 patients are diagnosed with heart failure each year.

What is Advanced Heart Failure?

Of the more than 6 million Americans living with heart failure, about 10 percent have advanced heart failure. The condition is considered advanced when conventional heart therapies and symptom management strategies no longer work. You feel shortness of breath and other symptoms even at rest.


WHAT DOES THE MARVEL TRIAL DO?

THE MARVEL TRIAL:

The MARVEL Clinical Program is designed to assess functional capacity and quality of life in patients with ADVANCED HEART FAILURE after receiving injection of adult muscle stem cell therapy in their damaged heart muscle

Official Title: A Multicenter Study to Assess the Safety and Cardiovascular Effects of Myocell™ Implantation by a Catheter Delivery System in Congestive Heart Failure Patients Post Myocardial Infarction(s)

THE IS NO CURE FOR HEART DISEASE.

THE ELIGIBLE PATIENTS FOR THE MARVEL TRIAL WERE CONSIDERED:

"Chronic CHF, New York Heart Association (NYHA) Class II-IV"

https://www.pennmedicine.org/updates/blogs/heart-and-vascular-blog/2014/september/heart-failure-classification--stages-of-heart-failure-and-their-treatments

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BUT FORGET ABOUT RMAT FOR A SECOND.

WHERE ARE WE AT WITH THE NEW LAWS????????????????????

GOD HELP US W/ THE GOVT.

HOW ARE WE GOING TO GET MYOCELL TO THE PATIENTS?

HERE WE GO:

NUMBER 1. THE "RIGHT TO TRY LAWS"

THE RIGHT TO TRY LAWS ARE DESIGNED FOR TERMINALLY ILL PEOPLE

Withholding experimental drugs from the most gravely ill has fueled several states to pass so-called "right-to-try" legislation that would make these drugs available without Food and Drug Administration approval to terminally ill patients with no other options.

Some critics of the years-long FDA drug approval process, with its requirement for multiple clinical trials, contend that it is much longer than it should be, thereby keeping some promising drugs from those who might benefit

Because of that, Colorado, Missouri and Louisiana all passed right-to-try legislation this year that would enable those with terminal illnesses and no other treatment options to secure investigational drugs after their first phase of clinical trials (there usually are at least three) before final FDA approval if the drug manufacturer is willing to provide them. Arizona voters will decide a similar measure in a referendum in November.

California, Connecticut, Georgia, Idaho, Maine, New Hampshire, South Carolina, and West Virginia passed versions of the law in 2016. Of the 17 states that have not passed right-to-try laws, the biggest are New York, New Jersey, Maryland, Massachusetts, Washington, and Pennsylvania.

The laws would cut the FDA out of the process, at least in terms of a single, terminally ill patient. The decision would be left entirely in the hands of the patient, the doctor and the drug company.

In Maryland, state senators were showing bipartisan support for a right-to-try bill earlier this month, according to the state Senator Bryan Simonaire, who authored the legislation.

HB 45 passed the State House unanimously in April, by a 193-0 vote. It is expected to land in the Senate Health and Human Services Committee this summer.

The FDA does not have an official stance on "right-to-try" laws. Nor does the Pennsylvania Medical Society.

(IN PENNSYLVANIA)
Under Godshall's "right-to-try" bill, patients would only be able to test drugs known by the FDA in their trial stages. A drug has to go through three testing phases, he says, typically lasting five to ten years. In other words, the bill does not approve or condone trying a foreign drug not known to FDA scientists.

In May 2014, Colorado became the first state to pass a right-to-try law.[3] As of May 2017, 37 states have enacted such laws: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Hampshire, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, and Wyoming

More than half the states in the country have passed Right to Try laws, and in most states the law has passed with bipartisan majorities and virtually no opposition. One state that passed it is Indiana, where then-governor, and now vice president, Mike Pence signed it into law.

OK SO PEOPLE WANNA ARGUE.

THAT THE STATES DONT HAVE THE RIGHT TO SUPERSEDE THE FEDS.
(You see how well that worked out for Colorado and Marijuanna ? )

BUT GET THIS.

Now there is a movement for Congress to pass a national right-to-try law, and the Trump administration is supportive of its goals.

In its deregulatory zeal, the Trump administration has endorsed federal legislation, called the Right to Try Act

The administration recently voiced support for “Right to Try” (RTT) advocates, after bills were introduced in the House and Senate that would put legislative force behind 33 state RTT laws. These laws claim to give terminally ill patients “compassionate” access to experimental drugs.
However, the laws do not operate as advertised: They do not provide access to unapproved drugs but merely the option of asking for such drugs from manufacturers, which are fully free to refuse.


CURRENT HEAD OF THE FDA SCOTT GOTTLIEB WAS ASKED TO COMMENT ON THE NATIONAL RIGHT-TO-TRY LAW IN APRIL 17'

Q: Given the Trump Administration’s support of right to try laws, please give your perspective on both the impact on patients, and drug development process, if the current federal legislative proposal was enacted.

GOTTLIEB'S ANSWER:

A: Access to off label and investigational products for patients facing serious and terminal illness is not an abstract issue to me. As a cancer survivor who used a commercially available combination therapy in an off label manner, I understand, at a very personal level, that patients who are fighting serious or life-threatening diseases want the flexibility to try new therapeutic approaches, including access to investigational medical products, particularly when there is no other FDA-approved treatment option. I also believe that the clinical trial process is crucial to the development of innovative new medical products that can improve or save patients’ lives. If confirmed, I would commit to ensuring FDA has the right policies and processes in place to appropriately balance individual patients’ needs for access to investigational therapies while recognizing the importance of maintaining a rigorous clinical trial paradigm for testing investigational products and demonstrating safety and efficacy. I would be happy to work with Congress as it considers Right-to-Try legislative proposals.

His answer is pretty clear: Gottlieb will fight for patients facing serious and terminal illnesses, because he has been one. And there is no contradiction between speeding access to investigational medicines for dying Americans and treatments and maintaining a rigorous clinical trial process.


VP MIKE PENC*E

"He`s very, very supportive. He understands the merits of it. He says that he and President Trump not only campaigned on it, but they plan on pushing it through. I know that`s Trickett's voice. That`s my wife`s voice driving that, and it feels like we`re going to carry it through and we`re going to push the bill all the way through," Tim Wendler said.

"He said 'we`re going to get this passed,'" Tealyn Wendler said.

http://fox6now.com/2017/02/07/family-of-trickett-wendler-meets-with-vp-pence-to-discuss-right-to-try-act/

S.204 - Trickett Wendler Right to Try Act of 2017

https://www.congress.gov/bill/115th-congress/senate-bill/204/text

SO, AFTER ALL THAT WHAT DID WE LEARN?

IMO. USRM IS UNLIKELY TO USE THE RIGHT TO TRY LAWS TO SELL MYOCELL YET, BECAUSE IT HAS NOT BEEN ENACTED ON A FEDERAL LEVEL.

BUT. THERE IS AN EXCEPTION.

ENTER: THE GREAT STATE OF TEXAS.

If passed, HB661 would effectively expand Right to Try to patients suffering from chronic illnesses.

NOT JUST TERMINALLY ILL PATIENTS BUT CHRONIC ILLNESSES.

Bill: HB 661

http://www.legis.state.tx.us/BillLookup/History.aspx?LegSess=85R&Bill=HB661

http://www.capitol.state.tx.us/tlodocs/85R/billtext/pdf/HB00661I.pdf

WHY IS 661 IMPORTANT?

Provisions in HB661 are similar to those in the current Right to Try law. Specifically, the legislation prohibits state officials from any actions that would prevent the lawful administering of experimental procedures to eligible patients. It reads, in part:

“An official, employee, or agent of this state may not block or attempt to block an eligible patient’s access to an investigational drug, biological product, or device.”

This is important, since local law enforcement often works closely with federal agencies to take aggressive actions to stop state program that aren’t in line with federal law. Including this provision ensures that the ‘boots on the ground’ for law enforcement – the locals, won’t be taking any action to stop sick people from trying new treatments. The feds will have to handle it, and they don’t have the manpower or resources to get the job done.

Healthcare providers are also protected under the bill, with a prohibition against revoking a license or issuing sanctions based on recommendation or issuance of such investigational treatments. Manufacturers of medications and treatments are shielded from legal recourse as well.

____________________________________________________________________________

THERE ARE 3 KEY BILLS RELATED TO STEM CELL THERAPY IN TEXAS. ONE OF WHICH BECAME LAW ALREADY.

HB 810, 661, AND 3236

June 13, 2017 /PRNewswire/ -- House Bill (HB 810) on stem cell therapy has passed in the Texas state legislature and become law. Patients in Texas will now have access to this "Right to Try" innovative form of therapy for those suffering with debilitating and incurable illnesses.

HB 661 would permit people with chronic illness to get therapies in early-stage clinical trials — not just terminally ill patients, as the state’s current “right-to-try” law does.

HB 3236 would allow companies to charge patients for unproven therapies.

NOW IF 661 AND 3236 PASS. THIS UNLOCKS THE LEGALITY OF SELLING A STEM CELL THERAPY THAT IS "MORE THAN MINIMALLY MANIPULATED" SUCH AS MYOCELL. IMO.

661 & 3236 HAS ALREADY PASSED THE HOUSE OF TEXAS.









TO GIVE YOU AN IDEA OF HOW FAST THIS CAN HAPPEN. CHECK OUT THE TIMELINE ON HB810 THAT WAS MADE LAW.



JUDGING BY THE OVERWHELMING SUPPORT FROM THE TEXAS HOUSE WITH 100% YES VOTES. THE ODDS ARE INCREASING FOR THE PROBABILITY OF NOT ONLY TERMINALLY ILL PATIENTS, BUT ALSO THOSE SUFFERING FROM EARLIER STAGE CHRONIC DISEASES RIGHT TO TRY, BUT ALSO STEM CELL CLINICS RIGHT TO PROFIT FROM IT.

IF TEXAS PASSES 661 AND 3236, AND THE GOVERNER SIGNS THEM, WE CAN POTENTIALLY SELL MYOCELL IN TEXAS LEGALLY UPON THE EFFECTIVE DATE.

IF TRICKETT WENDLER PASSES ON THE NATIONAL LEVEL, THE OTHER 37 STATES WILL HAVE THE OPPORTUNITY TO DO WHAT TEXAS IS DOING WITH 661 AND 3236

BUT WHAT ARE THE REAL IMPLICATIONS OF ALL OF THIS?

MY OPINION IS THAT A MAJOR ANNOUNCEMENT OF FDA REFORM WILL TAKE PLACE SOON.

IN MY OPINION GOTTLIEB WILL COMBINE THE TEXAS LAW, WITH GODSHALL'S PENNSYLVANNIA BILL, AND THE FEDERAL LAW, WHICH ALSO ACKNOWLEDGES THE CLINICAL TRIAL PHASE 1, AND POSSIBLY 2, WHICH MYOCELL ALREADY HAS THE CREDIBLE DATA FOR, AND HE. SCOTT GOTTLIEB WILL TRANSFORM THE WAY THAT PATIENTS ARE ALLOWED TO GET REGENERATIVE MEDICINE TREATMENTS.

Under Godshall's "right-to-try" bill, patients would only be able to test drugs known by the FDA in their trial stages. A drug has to go through three testing phases, he says, typically lasting five to ten years. In other words, the bill does not approve or condone trying a foreign drug not known to FDA scientists.

GOTTLIEBB WILL CONSOLIDATE THESE RIGHT TO TRY STATES.

RMAT DESIGNATION IS WHAT WE WANTED. AND IS STILL POSSIBLE.

BUT. TEXAS AND RIGHT TO TRY IS HAPPENING FAST.

HIPPO'S RMAT DEADLINE IS JULY 31ST
HIPPO'S TEXAS DEADLINE IS SEPTEMBER 1ST

SO EVEN IF RMAT DOES NOT HAPPEN.
TEXAS IS LIKELY TO HAPPEN SHORTLY AFTER.
OTHER STATES SOON TO FOLLOW.
TRICKETT WENDLER SOON TO FOLLOW.

MYOCELL WILL REACH THE MASSES IN MY OPINION.

MYOCELL IS PROJECTED TO COST $35-45,000 DOLLARS PER PATIENT

WE SHOULD BE ABLE TO GET 500 PATIENTS PER YEAR =
APPROXIMATELY 20 MILLION DOLLARS ANNUALLY IN REVENUES.

NOW WHAT IF, GEORGIA, FLORIDA, ILLINOIS, COLORADO, ETC.. FALL IN LINE?

WE START MULTIPLYING THOSE REVENUES ON MYOCELL ALONE FOR EACH CLINIC.

NOW LET ME REMIND YOU ONE MORE TIME.

RMAT CAN HAPPEN TODAY, TOMORROW, JULY 31ST, or
WE CAN GET DENIED, OR REQUEST MORE INFORMATION (AGAIN).

RMAT IS THE GOLD STANDARD FOR "FDA" STEM CELL THERAPIES.

ONLY 4 COMPANIES HAVE OBTAINED RMAT AS OF TODAY.

WE WANT IT.

WE DONT KNOW EXACTLY WHAT RMAT WILL DO FOR US YET.

BUT. ODDS ARE. IT WILL BE SIMILAR GUIDELINES SUCH AS THE OTHER 4 SERIOUS CONDITIONS PROGRAMS WHICH WILL MOST LIKELY MEAN WE CAN SELL IT IMMEDIATELY IN ALL 50 STATES POSSIBLY WITH CONDITIONS AND REPORTING.

THE DECISION IS IMMINENT.

IT WILL HAPPEN.

$USRM IS ON THE PATH TO PROFITABILITY.

THERE ARE CATALYST COMING, FAST.

ONE ANNOUNCEMENT FROM TRUM*P, GOTLIEBB OR THE FDA, COULD BLOW THE PPS UP.


Disclaimer: This post is my opinion only. Do your own DD and research.