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They gotta load before the run
Thanks for sharing that!
Now imagine that...
consolidated fins possibly with ev numbers
Name and ticker change
And massive short squeeze
ALL at the same time.
Every stem cell company should see green tomorrow with that news.
Undervalued... Capricor plans to apply for RMAT. They're trading at $3 currently.
Way undervalued here.
http://www.prnewswire.com/news-releases/capricor-therapeutics-announces-positive-six-month-results-from-the-randomized-phase-iii-hope-clinical-trial-in-duchenne-muscular-dystrophy-300444967.html
We'll be third designation imo
Coming soon
Has this been posted yet?
http://medcitynews.com/2017/04/enzyvant-regenerative-medicine-advanced-therapy-rmat-designation/
Who's next?
We'll be hearin from the ole FDA within two weeks imo
This reminds me of when we were in 04/05 for a while...
We all know what came next
About to get fun again
Not until the deal is consummated, which it appears has yet to happen.
Keep posting that DL
I don't think most people realize that FACT.
Should start getting fun here real soon.
Guess we'll find out eventually
You're assuming the FDA will take the entire 60 days. I think they have a pretty good idea of what heyre looking at by now. Also, what is the purpose of the RMAT?? It is to speed up the FDA review process. I'd think the FDA would want to act swiftly. Could be today, could be end of may. Guess we'll find out eventually
Woooo!! This a going to be a great week for DOLV.
Fins likely out this week showin us the goods.
Don't forget, tonight at 8:30est is 8:30 Monday morning in China.
Maybe a ticker/name change.
!!!
Touché
I still stand by my statement that usrm was already way up by that time, coming from trips. You are correct though 10x from that time.
Doesn't change the fact that the FDA is about to get real lax with their approval process :)
Wrong. The stock was already way up by the time the CEO blogged that.
What is a consolidated financial statement? Here ya go...
"Consolidated financial statements are the combined financial statements of a parent company and its subsidiaries. Because consolidated financial statements present an aggregated look at the financial position of a parent and its subsidiaries, they let you gauge the overall health of an entire group of companies as opposed to one company's standalone position."
Read more: Consolidated Financial Statements http://www.investopedia.com/terms/c/consolidatedfinancialstatement.asp#ixzz4f0rqH64s
http://www.investinganswers.com/financial-dictionary/financial-statement-analysis/consolidated-financial-statements-2293
"Let's assume Company XYZ is a holding company that owns four other companies: Company A, Company B, Company C, and Company D. Each of the four companies pays royalties and other fees to Company XYZ.
At the end of the year, Company XYZ's income statement reflects a large amount of royalties and fees with very few expenses -- because they are recorded on the subsidiary income statements. An investor looking solely at Company XYZ's holding company financial statements could easily get a misleading view of the entity's performance.
However, if Company XYZ consolidates its financial statements -- "adding" the income statements, balance sheets, and cash flow statements of XYZ and the four subsidiaries together -- the results give a more complete picture of the whole Company XYZ enterprise.
In Figure 1 below, Company XYZ's assets are only $1 million, but the consolidated number shows that the entity as a whole controls $213 million in assets.
In the real world, generally accepted accounting principles (GAAP) require companies to eliminate intercompany transactions from their consolidated statements. This means they must exclude movements of cash, revenue, assets, or liabilities from one entity to another in order to avoid double counting them. Some examples include interest one subsidiary earns from a loan made to another subsidiary, "management fees" that a subsidiary pays the parent company, and sales and purchases among subsidiaries.
Consolidated financial statements provide a comprehensive overview of a company's operations. Without them, investors would not have an idea of how well an enterprise as a whole is doing.
GAAP dictates when and how statements should be consolidated, and whether certain entities need to be consolidated. Companies who only own a minority interest in an entity usually do not need to consolidate them on their statements. For example, if Company XYZ owned only 5% of Company A, it would not have to consolidate Company A's financial statements with its own.
Companies commonly break out their consolidated statements by division or subsidiary so investors can see the relative performance of each, but in many cases this is not required, especially if the company owns 100% of the division or subsidiary."
My bad, will do.
He's actually been very outspoken about supporting revolutionary medicines, including stem cells and medical marijuana.
https://www.google.com/amp/s/www.forbes.com/sites/scottgottlieb/2016/01/12/fda-needs-to-change-how-it-regulates-novel-technologies/amp/
I spoke before a meeting of the International Society for Stem Cell Research in Berkeley, Calif., this week, addressing the need for the Food and Drug Administration to adapt how it approaches pre-market regulation in order to properly address very novel areas of technology like gene editing and cell and gene therapy.
Another great Scott Gottlieb link! We're golden here...
https://www.google.com/amp/reason.com/blog/2017/03/13/scott-gottlieb-trumps-nominee-for-food-a/amp
Gottlieb, who has been associated with venture capital side of medical innovation, will seek to change the agency's culture from the current highly precautionary approach to one that more readily recognizes that benefits always come with risks. Under his direction, the agency would likely exercise a lighter regulatory hand over the development of new medical apps and diagnostics while seeking to work out the best way to speed up the approval of novel therapeutics based on stem cells and gene-edting technologies like CRISPR.
Gottlieb has spoken extensively about his stance on stem cells. He's all about it, google pulls up many articles written by him on this matter. Also, don't look too much into his relationships with big pharma. Yeah, he's got some ties there but on the other side he's also been an advocate of medical marijuana and even prescribed it as a doctor.
He wants to expand healthcare and innovation. His boss, trump, wants cheaper healthcare. Deregulation of the FDA will be a first step in creating cheaper medicine. Think about it. Less money spent on expensive trials means less costly medicine, in theory atleast
Scott Gottlieb will want to prove a point.
And imo he'll use US Stem Cell to do it
The first stem cell company to receive RMAT designation under his reign.
He takes over next week
New FDA director will be confirmed next week >>
https://www.forbes.com/sites/scottgottlieb/2016/01/12/fda-needs-to-change-how-it-regulates-novel-technologies/#37a7a755191e
Sounds like a friend of usrm
RMAT news and this thing flies into another galaxy. Chart is primed and ready
No doubt
We are golden here. Everything written in the FDA guidelines for an RMAT designation has been covered by usrm. Most people just haven't read those guidelines and think we need phase 3 trials haha
RMAT was designed to get a company to full approval without undergoing the extensive and expensive phase 3 trials.
Like taking candy from a baby here.
Wrong, read this:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=130642833
People know what you have here!
The grass is growing
They never promised us anything. They intended for the financials to be out this week, but the auditor is taking longer than anticipated. Don't be surprised to see it AH today.
Exactly.. the companies assets and details are what I'm here for. The revenue will come.
Now if they throw some contract info in there. $$$!
Looks like she has some very prominent DOCTORS also endorsing her on LinkedIn
Furthermore, she has some pretty big name CEO's endorsing her on LinkedIn
http://peopleunlimitedinc.com/posts/
The Winter Super Longevity Week featured several shining stars from the field of radical life extension. Guest speakers included Dr. Kristin Comella of US Stem Cell, Dr. Jose Cordeiro of Singularity University, Bill Faloon of Life Extension and the co-author and physicianDr. TerryGrossman, all experts in their fields and members of the Coalition for Radical Life Extension and presenters at RAADfest in 2016, and upcoming in 2017.
Dr. Comella gave a very exciting presentation on regenerative medicine with adipose stem cells, bringing the age of pharmaceuticals to a close, and revolutionizing medicine with personalized treatment utilizing the individual’s own stem cells. Dr. Cordeiro was his usual radically energetic self, talking about the revolution that will kill aging and death. An expert on AI, he always brings his unique perspective on the future, for example 3D printing of body parts, enhancing our brains with an exocortex and designing our future children. Bill Faloon from Life Extension Foundation was an enormous resource of knowledge of different technologies for human age reversal, and he touched on many subjects with energy and clarity. His tireless dedication to end human suffering from aging is truly inspirational. Dr. Terry Grossman gave a detailed presentation on the best diets for radical life extension based on medical studies. Various diets were discussed with their pros and cons and information on how to choose the best way to eat to increase longevity.
%.008 of the OS has traded today. LOW VOLUME takedown
People are holding for RMAT designation. So obvious
Again, read the RMAT guidelines from the FDA! They don't even need any trial info to apply!! Nowhere does it mention, in the slightest indication, needing NEW trials. If I missed that somewhere please correct me.
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
We refer you to the Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics, section III.A., for FDA’s interpretation of whether a disease or condition is serious or life-threatening and whether a drug is intended to treat a serious disease or condition.
The request for RMAT designation must be made either concurrently with submission of an Investigational New Drug application (IND) or as an amendment to an existing IND. We will not grant a RMAT designation if an IND is on hold or is placed on hold during the designation review.
We generally do not expect you to submit primary data (data sets), but your request for regenerative advanced therapy designation should describe the preliminary clinical evidence. Please include a brief description of any available therapies for the disease or condition, the study design, the population studied, and the endpoint(s) used; and a description of the study results and statistical analyses (e.g., subgroup analyses).
You may submit a request for RMAT designation to:
Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Tissues and Advanced Therapies
Document Control Center
10903 New Hampshire Avenue
WO71, G112
Silver Spring, MD 20993-0002
If the RMAT designation request is submitted to your IND as an amendment, the cover letter should specify that the submission contains a REQUEST FOR REGENERATIVE MEDICINE ADVANCED THERAPY DESIGNATION in bold, uppercase letters. If the request is submitted with an initial IND, the cover letter should specify that the submission contains both an INITIAL INVESTIGATIONAL NEW DRUG SUBMISSION and REQUEST FOR REGENERATIVE MEDICINE ADVANCED THERAPY DESIGNATION in bold, upper case letters.
No later than 60 calendar days after receipt of the designation request, the Office of Tissues and Advanced Therapies (OTAT) will notify the sponsor as to whether RMAT designation has been granted. If OTAT determines that the RMAT designation request was incomplete or that the drug development program does not meet the criteria for RMAT designation, OTAT will include a written description of the rationale for such determination.
My previous post answers his misunderstandings thoroughly. We're good here. FDA news is coming
Again, read the RMAT guidelines from the FDA! They don't even need any trial info to apply!! Nowhere does it mention, in the slightest indication, needing NEW trials. If I missed that somewhere please correct me.
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
We refer you to the Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics, section III.A., for FDA’s interpretation of whether a disease or condition is serious or life-threatening and whether a drug is intended to treat a serious disease or condition.
The request for RMAT designation must be made either concurrently with submission of an Investigational New Drug application (IND) or as an amendment to an existing IND. We will not grant a RMAT designation if an IND is on hold or is placed on hold during the designation review.
We generally do not expect you to submit primary data (data sets), but your request for regenerative advanced therapy designation should describe the preliminary clinical evidence. Please include a brief description of any available therapies for the disease or condition, the study design, the population studied, and the endpoint(s) used; and a description of the study results and statistical analyses (e.g., subgroup analyses).
You may submit a request for RMAT designation to:
Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Tissues and Advanced Therapies
Document Control Center
10903 New Hampshire Avenue
WO71, G112
Silver Spring, MD 20993-0002
If the RMAT designation request is submitted to your IND as an amendment, the cover letter should specify that the submission contains a REQUEST FOR REGENERATIVE MEDICINE ADVANCED THERAPY DESIGNATION in bold, uppercase letters. If the request is submitted with an initial IND, the cover letter should specify that the submission contains both an INITIAL INVESTIGATIONAL NEW DRUG SUBMISSION and REQUEST FOR REGENERATIVE MEDICINE ADVANCED THERAPY DESIGNATION in bold, upper case letters.
No later than 60 calendar days after receipt of the designation request, the Office of Tissues and Advanced Therapies (OTAT) will notify the sponsor as to whether RMAT designation has been granted. If OTAT determines that the RMAT designation request was incomplete or that the drug development program does not meet the criteria for RMAT designation, OTAT will include a written description of the rationale for such determination.
PHD candidate! Meaning she has completed ALL coursework and is working on research/thesis.
I don't think hd understands the phd process, I wouldn't expect him too
https://www.google.com/amp/reason.com/blog/2017/03/13/scott-gottlieb-trumps-nominee-for-food-a/amp
Gottlieb, who has been associated with venture capital side of medical innovation, will seek to change the agency's culture from the current highly precautionary approach to one that more readily recognizes that benefits always come with risks. Under his direction, the agency would likely exercise a lighter regulatory hand over the development of new medical apps and diagnostics while seeking to work out the best way to speed up the approval of novel therapeutics based on stem cells and gene-edting technologies like CRISPR.
Mr Gottlieb will certainly wish to find more ways of speeding drug approvals.The agency has done much on this front already. Yet inconsistency continues: some divisions of the FDA respond to routine inquiries from companies in a few weeks; others take three months. Mr Gottlieb has also criticised the agency for having a culture that values “excessive desire for certainty”. Attempts to change this will elicit criticism that patient safety is in jeopardy. Yet in some cases it is clear that the demand for ever-larger clinical trials of new drugs has done little for safety, raised costs and rewarded chiefly the very largest companies that can afford to run them.
One path will be to advance the trend for gathering evidence from trials that take place in the real world, not under tightly controlled conditions. GlaxoSmithKline, a British pharmaceutical group, recently completed the world’s first such test for a drug, Relvar, which treats asthma and chronic obstructive pulmonary disease. The four-year trial was conducted by monitoring thousands of patients’ electronic medical records.
Generic drugs is another area where Mr Gottlieb has signalled his views. In a commentary for the Wall Street Journal in August, he criticised the policymaking that had kept some generic medicines off the market, raising prices. He may want to tackle the rising cost and complexity of filing applications to market generic drugs—the problem that allowed Martin Shkreli, a controversial entrepreneur, to raise the price of Daraprim, an anti-parasitic drug, by 5,000% in 2015, causing fury.
The FDA also needs to run faster to keep abreast of innovation. Sudip Parikh, a policy adviser at the Drug Information Association, another think-tank, says the rate of change means that decades-old rules and regulations may not function well for new treatments. Some rules will be too restrictive, others too permissive. On the one hand, for example, more should be done to allow digital health-care products to escape the grasp of the FDA; on the other, the use of stem cells should face more scrutiny. Many clinics offer unregulated stem-cell treatments because of a loophole in the law. Three people were recently found to have been blinded by such treatments.
Wrong.. you need to read the RMAT guidelines before posting false info about it..
They would've just denied it if that was the case, which I don't see any denial from FDA. The whole point of RMAT and the cures act is to get medicine up and running WITHOUT extensive trials. Lol
Also google Scott Gottlieb. He's in charge of the FDA now