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ONLY SNDL IS DEBT FREE. OTHER CANNABIS COMPANIES HAVE HUGE DEBT. https://www.fool.com/investing/2019/04/21/5-marijuana-stocks-with-the-most-debt-should-inves.aspx
Company Total Long-Term Debt
Constellation Brands (NYSE:STZ) $13.6 billion
Scotts Miracle-Gro (NYSE:SMG) $2 billion
Aurora Cannabis (NYSE:ACB) $599 million
Tilray (NASDAQ:TLRY) $420.4 million
Aphria (NASDAQ:APHA) $46.7 million”
"While many cannabis companies have significant debt burdens, Sundial is proud to announce that we are now debt-free," said Zach George, Sundial's CEO. ... Through a combination of asset sales, debt for equity swaps, capital raises, and cash repayments, we have eliminated $227 million in debt this year.“
https://www.prnewswire.com/news-releases/sundial-announces-completion-of-financial-restructuring-and-debt-free-status-301196607.html
“Following the closing of the offering, Sundial has unrestricted cash of approximately $610 million, in addition to marketable securities and loans receivable of approximately $61 million, and approximately 1.56 billion common shares outstanding.” https://ca.finance.yahoo.com/news/flower-one-announces-successful-closing-160900347.html
READ: ONLY SNDL DEBT FREE. OTHER COMPANIES IN DEBT.https://www.fool.com/investing/2019/04/21/5-marijuana-stocks-with-the-most-debt-should-inves.aspx
Company Total Long-Term Debt
Constellation Brands (NYSE:STZ) $13.6 billion
Scotts Miracle-Gro (NYSE:SMG) $2 billion
Aurora Cannabis (NYSE:ACB) $599 million
Tilray (NASDAQ:TLRY) $420.4 million
Aphria (NASDAQ:APHA) $46.7 million”
"While many cannabis companies have significant debt burdens, Sundial is proud to announce that we are now debt-free," said Zach George, Sundial's CEO. ... Through a combination of asset sales, debt for equity swaps, capital raises, and cash repayments, we have eliminated $227 million in debt this year.“
https://www.prnewswire.com/news-releases/sundial-announces-completion-of-financial-restructuring-and-debt-free-status-301196607.html
“Following the closing of the offering, Sundial has unrestricted cash of approximately $610 million, in addition to marketable securities and loans receivable of approximately $61 million, and approximately 1.56 billion common shares outstanding.” https://ca.finance.yahoo.com/news/flower-one-announces-successful-closing-160900347.html
Watch video (& see 4:37):
About the Reverse Split: “ - Special Meeting of Stockholders Scheduled for January 26, 2021 Seeking Authorization to Potentially Effectuate a Discretionary Reverse Stock Split Prior to January 26, 2022.”
https://www.globenewswire.com/news-release/2020/12/07/2140379/0/en/Matinas-BioPharma-Files-Preliminary-Proxy-for-Special-Meeting-of-Stockholders.html
MTNB inside buyers will not vote to split their inside-purchased stock, without guaranteeing that their shares will not be affected. There is something very peculiar about this scenario. And it looks like MTNB is in on it. Why would MTNB have a special meeting-vote to split the stock after their inside buys? Did anyone hear anything about the meeting and the votes?
Or is it that the insiders plan to sell their shares before and for how much? Be careful. There’s something strange going on here. And since they are talking reverse split, with Market Maker manipulation, says the company doesn’t look good. So they need the Market Maker to play LIQUIDITY games at 6:05 AM for a $2.35 spike that’s at $1.25 a day later and not the same day. The $2.35 was Market Maker Money - - it had to be. So how can a split be needed, if MAT9001 and LNC are as good as they say. LNC, by concept, would be the first drug delivery system to cross the Blood Brain Barrier. LNC IS A DISRUPTIVE BREAK THROUGH. LNC CAN PUT PHARMACEUTICAL COMPANIES OUT OF BUSINESS. I BELIEVE THAT MTNB IS IN SOME SORT OF TROUBLE, BECAUSE OF LNC. AND I ALSO STRONGLY BELIEVE THAT BIG PHARMA IS BEHIND THIS. LNC WAS REVIEWED BY MULTIPLE BIG PHARMA COMPANIES. IF BIG PHARMA IS STILL CHECKING LNC OUT, THEN MTNB IS BEING THREATENED OR BLACKMAILED. I CAN ASSURE YOU THAT REMDISIVIR DOES NOT NEED LNC DELIVERY. REMDISIVIR WAS ADMINISTERED WITHOUT LNC. SOMETHING IS GOING ON HERE. I BELIEVE THAT MTNB IS IN SOME SORT OF TROUBLE WITH BIG PHARMA GOONS.
And watch this video:
Watch this video:
Look at the inside buys: https://www.matinasbiopharma.com/investors/sec-filings/section-16-filings?form_type=&year=2021
https://www.matinasbiopharma.com/investors/sec-filings/section-16-filings?form_type=&year=2021
https://www.matinasbiopharma.com/investors/sec-filings/section-16-filings?form_type=&year=2021
https://www.matinasbiopharma.com/investors/sec-filings/section-16-filings?form_type=&year=2021
https://www.matinasbiopharma.com/investors/sec-filings/section-16-filings?form_type=&year=2021##document-5920-0001493152-21-000130
https://www.matinasbiopharma.com/investors/sec-filings/section-16-filings?form_type=&year=2021##document-5919-0001493152-21-000132
https://www.matinasbiopharma.com/investors/sec-filings/section-16-filings?form_type=&year=2021
BZ: UPDATE: “Matinas BioPharma Announces 'LYPDISO™ demonstrated a statistically significant 46% relative percent increase in EPA (eicosapentaenoic acid) change from baseline over Vascepa”
It was not a clinical trial result. It was only head to head. The results were super. But many don’t understand them, yet. This is why price went up. Shorts brought price down. This can still fly.
Look at fourth slide from bottom: https://www.sec.gov/Archives/edgar/data/1582554/000149315221000992/ex99-1.htm
MAT9001 & Vascepa are studied “as adjuncts to statins.” They we’re not administered alone. MAT9001 blew VASCEPA away - - “as an adjunct to statin therapy.” Therefore MAT9001 has higher efficacy than VASCEPA alone and with Statins. VASCEPA is weaker and less effective.
READ: https://pubmed.ncbi.nlm.nih.gov/28391875/
Background: Long-chain omega-3 fatty acid concentrate pharmaceuticals are used in the United States for treatment of severe hypertriglyceridemia (≥500 mg/dL) and are under investigation as adjuncts to statins for lowering cardiovascular risk in patients with high triglycerides (TGs; 200-499 mg/dL).
Objective: To evaluate MAT9001, an investigational prescription-only omega-3 fatty acid agent containing predominantly eicosapentaenoic acid (EPA) and docosapentaenoic acid, in 42 men and women with fasting TG 200 to 400 mg/dL.
Methods: In this open-label, crossover trial, subjects received MAT9001 and EPA ethyl esters (EPA-EE) in random order. They were housed in a clinical research unit for 2 14-day treatment periods, separated by a ≥35-day washout. Lipoprotein lipids, apolipoproteins (Apos) and proprotein convertase subtilisin kexin type 9 levels were measured before and at the end of each treatment period.
Results: MAT9001, compared with EPA-EE, resulted in significantly (P < .05) larger reductions from pretreatment levels for TG (-33.2% vs -10.5%), total cholesterol (-9.0% vs -6.2%), non-high-density lipoprotein cholesterol (-8.8% vs -4.6%), very low-density lipoprotein cholesterol (-32.5% vs -8.1%), Apo C3 (-25.5% vs -5.0%), and proprotein convertase subtilisin kexin type 9 (-12.3% vs +8.8%). MAT9001 also produced a significantly (P = .003) larger reduction in Apo A1 (-15.3% vs -10.2%), but responses for high-density lipoprotein cholesterol (-11.3% vs -11.1%), low-density lipoprotein cholesterol (-2.4% vs -4.3%), and Apo B (-3.8% vs -0.7%), respectively, were not significantly different relative to EPA-EE.
Conclusions: MAT9001 produced significantly larger reductions than EPA-EE in several lipoprotein-related variables that would be expected to favorably alter cardiovascular disease risk in men and women with hypertriglyceridemia.
Trial registration: ClinicalTrials.gov NCT02310022.
Keywords: Docosapentaenoic acid; Eicosapentaenoic acid; Hypertriglyceridemia; Omega-3 fatty acids; Proprotein convertase subtilisin kexin type 9; Triglycerides.
See pp. 7 https://www.fda.gov/media/87374/download
“III.Research Use Only and Investigational Use Only In Vitro Diagnostic Products
Both RUO and IUO products are IVD products currently under development and not approved for clinical diagnostic use. Because they are being shipped for investigations pertaining to product development and not clinical use, these products are exempt from most regulatory controls including IDE regulation. The term RUO refers to devices that are in the laboratory phase of development. The term IUO refers to devices that are in the product testing phase of development.
A. Research Use Only In Vitro Diagnostic Products
An RUO product is an IVD product that is in the laboratory research phase of development and is being shipped or delivered for an investigation that is not subject to part 812. During the research phase of development, the focus of manufacturer-initiated studies is typically to evaluate design, limited-scale performance, and issues such as usability of the test. Some examples of products FDA would consider to be in this research phase include:
• Tests that are in development to identify test kit methodology, necessary components, and analytes to be measured.
• Instrumentation, software, or other electrical/mechanical components under development to determine correct settings, subcomponents, subassemblies, basic operational characteristics, and possible use methods.
• Reagents under development to determine production methods, purification levels, packaging needs, shelf life, storage conditions, etc.
FDA also recognizes that there are certain products, such as instruments, systems, and reagents that are labeled for research use only and intended for use in the conduct of non- clinical laboratory research with goals other than the development of a commercial IVD product, i.e., these products are used to carry out research and are not themselves the object of the research. These include products intended for use in discovering and developing medical knowledge related to human disease and conditions. For example, instruments and reagents intended for use in research attempting to isolate a gene linked with a particular disease may be labeled for research use only when such instruments and reagents are not intended to produce results for clinical use.”
PATENTS ARE NOT FDA-CVM APPROVALS. YOU CAN PATENT THE GENE IN YOUR BODY. DOESN’T MEAN IT WILL SELL. FDA-CVM ALREADY ISSUED THE INVESTIGATIONAL USE ONLY STAMP. FDA APPROVAL IS MILES AWAY FROM INVESTIGATIONAL USE. INVESTIGATIONAL USE DEVICES ARE ONLY FOR INVESTIGATION OF THE DEVICES’ FUNCTION. INVESTIGATIONAL USE ONLY FINDINGS MUST BE CONFIRMED BY APPROVED DIAGNOSTIC PROCESS. INVESTIGATIONAL USE DEVICES CANNOT BE USED OR IMPLEMENTED AS FINAL OR CONCRETE PATHOLOGICAL DIAGNOSTIC DEVICES.
Zomedica can have a million patents. PATENTS ARE NOT FDA APPROVALS FOR DIAGNOSTIC DEVICES.
READ FDA LINK: https://www.fda.gov/about-fda/fda-organization/center-veterinary-medicine
FDA’s Center for Veterinary Medicine (CVM): “Protecting Human and Animal Health.” To achieve this broad mission, CVM:
Makes sure an animal drug is safe and effective before approving it. The center approves animal drugs for companion (pet) animals, such as dogs, cats, and horses; and for food-producing animals, such as cattle, pigs, chickens, and even honey bees. If the drug is for a food-producing animal, before approving it, the center also makes sure that food products made from treated animals—meat, milk, eggs, and honey—are safe for people to eat;
Monitors the safety and effectiveness of animal drugs on the market;
Makes sure animal food—which includes animal feed, pet food, and pet treats—is safe, made under sanitary conditions, and properly labeled;
Makes sure a food additive used in animal food is safe and effective before approving it;
Conducts research that helps the center ensure the safety of animal drugs, animal food, and food products made from animals; and
Helps make more animal drugs legally available for minor species, such as fish, hamsters, and parrots; and for minor (infrequent and limited) uses in a major species, such as cattle, turkeys, and dogs.
Meet Dr. Steven Solomon, Director, Center for Veterinary Medicine
What CVM Regulates
Animal Drugs
Animal Food & Feeds (which includes pet food)
Animal Medical Devices
Frequently Asked Questions about Animal Drugs
Information for Veterinarians
See pp 28: https://sec.report/Document/0001171843-19-001229/
“Some of our products may or may not be covered by a patent. Further if an application is filed, it is not certain that a patent will be granted or if granted whether it will be held to be valid. All of which may impact our market share and ability to prevent others (competitor third parties) from making, selling, or using our products.
We intend to rely upon a combination of regulatory exclusivity periods, patents, trade secret protection, confidentiality agreements, and license agreements to protect the intellectual property related to our current product candidates and our development programs. We may not be successful in protecting our intellectual property rights, including our unpatented proprietary know-how and trade secrets, or in avoiding claims that we infringed on the intellectual property rights of others. In addition to relying on patent and trademark rights, we rely on unpatented proprietary know-how and trade secrets, and employ various methods, including confidentiality agreements with employees and consultants, customers and suppliers to protect our know-how and trade secrets. However, these methods and our patents and trademarks may not afford complete protection and there can be no assurance that others will not independently develop the know-how and trade secrets or develop better production methods than us. Further, we may not be able to deter current and former employees, contractors and other parties from breaching confidentiality agreements and misappropriating proprietary information and it is possible that third parties may copy or otherwise obtain and use our information and proprietary technology without authorization or otherwise infringe on our intellectual property rights. In the future, we may also rely on litigation to enforce our intellectual property rights and contractual rights, and, if not successful, we may not be able to protect the value of our intellectual property. Any litigation could be protracted and costly and could have a material adverse effect on our business and results of operations regardless of its outcome.
If we are unable to obtain trademark registrations for our products our business could be adversely affected.
We have pending trademark applications for our company name and composite marks comprised of our company name, logo and/or slogan in the U.S., Canada, European Union, the United Kingdom, Brazil and Mexico. In addition, we have pending trademark applications for our “Voice of the Vet” mark in the U.S. and Canada. We have secured two registrations in the European Union for our company name and logo and for the mark Voice of the Vet powered by Zomedica & Design. While we cannot make assurances that these trademark applications will mature to registration in any pending jurisdiction, some of these applications are poised to mature to registration. The applications in Brazil and Mexico were recently filed, and we may face rejections to one or more of our pending trademark applications. Although we are given an opportunity to respond to those rejections, we may be unable to overcome such rejections. In addition, in most jurisdictions, third parties are given an opportunity to oppose pending trademark applications and to seek to cancel registered trademarks. Opposition or cancellation proceedings may be filed against our trademark applications/registrations, and our trademark applications/registrations may not survive such proceedings.
In particular, the European Union Intellectual Property Office recently determined that our proposed trademark application for certain contested goods and services was likely to cause confusion with an existing registered trademark. The opponent in that matter has also opposed trademark applications in Canada for our company name and logo, but did not oppose our applications in the United States after it sent a letter to us in June 2016 demanding that we cease use of the Zomedica mark and abandon all applications for such mark. While we believe that our mark does not violate any trademark rights of the opponent, we can provide no assurance that we will ultimately prevail in the Canadian opposition.”
BEWARE and READ: FDA HATES BIOSENSOR DEVICES. GET OUT OF THIS COMPANY.
See pp. 14: https://sec.report/Document/0001171843-19-001229/
“Risks Related to our Business
We have a limited operating history, are not profitable and may never become profitable.
We are a development stage veterinary diagnostic and pharmaceutical company creating products for companion animals (canine, feline and equine) by focusing on the unmet needs of clinical veterinarians. Since the commencement of our business in May 2015, our operations have been primarily limited to the identification of product candidates and research and development of our diagnostic and drug product candidates. As a result, we have limited historical operations upon which to evaluate our business and prospects and we have not yet demonstrated an ability to obtain approval for any of our product candidates or successfully overcome the risks and uncertainties frequently encountered by companies in emerging fields such as the companion animal pharmaceuticals and health care solutions industries.”
See pp. 15: https://sec.report/Document/0001171843-19-001229/
“We will need to raise additional capital to achieve our goals.
We do not have any products approved for sale. Although we believe that we do not require pre-market approval from the U.S. Food and Drug Administration’s Center for Veterinary Medicine, or the FDA-CVM, to market and sell ZM-024, a Bulk Acoustic Wave sensor-based veterinary point-of-care diagnostic platform for performing immunodiagnostic testing, ZM-020, our Raman spectroscopy-based point-of-care diagnostic platform, or ZM-017, the circulating tumor cell, or CTC, diagnostic assay that we are developing, we do not expect to commence marketing of these solutions until the first half of 2020.
Until, and unless, we receive approval from the FDA-CVM for our drug product candidates, we cannot market or sell our drug products in the United States and will have no material drug product revenue. Our lead drug product candidates are in the formulation, optimization and/or pilot study stage, and we have not yet begun pivotal trials. We anticipate that each of our drug product candidates will require approximately five years of development at a cost of approximately $6 million per drug product candidate before we expect to be able to apply for marketing approval in the United States. In addition, certain assays that we may choose to pursue for use in our diagnostic platforms may require pre-market regulatory approval.
See pp. 16:
“We face unproven markets for our products candidates.
The companion animal therapeutic and diagnostic markets are less developed than the human therapeutic and diagnostic markets and as a result no assurance can be given that our product candidates will be successful. Veterinarians, pet owners or other veterinary health providers in general may not accept or utilize any products that we may develop.
-16-
The companion animal care industry is subject to rapidly changing technology, which could make our product candidates obsolete.
The companion animal care industry is characterized by rapid technological changes, frequent new product introductions and enhancements, and evolving industry standards, all of which could make our product candidates obsolete. Our future success will depend on our ability to keep pace with the evolving needs of our customers on a timely and cost-effective basis and to pursue new market opportunities that develop as a result of technological and scientific advances. We must continuously enhance our product offerings to keep pace with evolving standards of care. If we do not update our product offerings to reflect new scientific knowledge or new standards of care, our product candidates could become obsolete, which would have a material adverse effect on our business, financial condition, and results of operations.”
See pp. 19:
The FDA-CVM or the USDA-CVB can delay, limit, deny or revoke approval of any of our product candidates for many reasons, including:
• if the FDA-CVM or USDA-CVB disagrees with our interpretation of data from our pivotal studies or other development efforts;
• if we are unable to demonstrate to the satisfaction of the FDA-CVM or the USDA-CVB that the product candidate is safe and effective for the target indication;
• if the FDA-CVM or USDA-CVB requires additional studies or changes its approval policies or regulations;
• if the FDA-CVM or USDA-CVB does not approve of the formulation, labeling or the specifications of our existing and future product candidates;
• if the FDA-CVM or USDA-CVB fails to approve the manufacturing processes of our third-party contract manufacturers; and
• if any approved product candidate subsequently fails post-approval testing required by the FDA-CVM or the USDA-CVB.
-19- (THIS IS WHY IT IS INVESTIGATIONAL USE ONLY. AND THE FDA DECIDED ALREADY).
Further, even if we receive approval of our product candidates, such approval may be for a more limited indication than we originally requested, the FDA-CVM or USDA-CVB may not approve the labeling that we believe is necessary or desirable for the successful commercialization of our product candidates and we may be required to conduct costly post-approval testing. Any delay or failure in obtaining applicable regulatory approval for the intended indications of our product candidates would delay or prevent commercialization of such product candidates and would materially adversely impact our business and prospects.
See pp. 25:
“We may acquire other businesses or form joint ventures that may be unsuccessful and could adversely dilute your ownership of our company.
As part of our business strategy, we may pursue in-licenses or acquisitions of other complementary assets and businesses and may also pursue strategic alliances. We have no experience in acquiring other assets or businesses and have limited experience in forming such alliances. We may not be able to successfully integrate any acquisitions into our existing business, and we could assume unknown or contingent liabilities or become subject to possible stockholder claims in connection with any related-party or third-party acquisitions or other transactions. We also could experience adverse effects on our reported results of operations from acquisition-related charges, amortization of acquired technology and other intangibles and impairment charges relating to write-offs of goodwill and other intangible assets from time to time following an acquisition. Integration of an acquired company requires management resources that otherwise would be available for ongoing development of our existing business. We may not realize the anticipated benefits of any acquisition, technology license or strategic alliance.
To finance future acquisitions, we may choose to issue shares of our common stock as consideration, which would dilute your ownership interest in us. Alternatively, it may be necessary for us to raise additional funds through public or private financings. Additional funds may not be available on terms that are favorable to us and, in the case of equity financings, may result in dilution to our stockholders.
Risks Related to Government Regulation
Various government regulations could limit or delay our ability to develop and commercialize our products or otherwise negatively impact our business.
In the U.S., the manufacture and sale of certain diagnostic products are regulated by agencies such as the USDA, the FDA or the EPA. While our point-of-care Bulk Acoustic Wave sensor-based diagnostic platform and Raman spectroscopy-based diagnostic platform and our reference lab-based diagnostic test for canine cancer do not require approval by the USDA-CVB prior to sale in the U.S., these diagnostic solutions will be subject to post-marketing oversight by the FDA-CVM. In addition, delays in obtaining regulatory approvals for new products or product upgrades could have a negative impact on our growth and profitability.
The manufacture and sale of our products, as well as our research and development processes, are subject to similar and potentially more stringent laws in foreign countries.
We are also subject to a variety of federal, state, local and international laws and regulations that govern, among other things, the importation and exportation of products; our business practices in the U.S. and abroad, such as anti-corruption and anti-competition laws; and immigration and travel restrictions. These legal and regulatory requirements differ among jurisdictions around the world and are rapidly changing and increasingly complex. The costs associated with compliance with these legal and regulatory requirements are significant and likely to increase in the future.”
Investigational use warning: “ANN ARBOR, Mich., Nov. 27, 2018 (GLOBE NEWSWIRE) -- Zomedica Pharmaceuticals Corp. (NYSE American: ZOM) (TSX-V: ZOM), a veterinary diagnostic and pharmaceutical company, today announced it has entered into a development and supply agreement with Qorvo Biotechnologies, LLC (Qorvo), a wholly-owned subsidiary of Qorvo, Inc. (Nasdaq: QRVO) focused on bringing its piezo-electric Bulk Acoustic Wave (BAW) sensor to the veterinary health sector. Under the terms of this agreement, Zomedica has exclusive, global rights to develop and market Qorvo's investigational point-of-care diagnostic platform for veterinary use.”
https://www.qorvo.com/newsroom/news/2018/zomedica-signs-exclusive-agreement-with-qorvo-biotechnologies-for-global-vet-rights-to-point-of-care
READ CAREFULLY, GET OUT OF ZOM: Bulk Acoustic Wave is Research / Investigational USE ONLY.
“Zomedica Signs Exclusive Agreement with Qorvo Biotechnologies for Global Veterinary Rights to Diagnostic Point-of-Care Platform SENSOR-BASED TECHNOLOGY AIMS TO PROVIDE VETERINARIANS WITH COLLECTION OF RAPID REFERENCE-LAB QUALITY TESTS AT THE POINT-OF-CARE
ANN ARBOR, Mich., Nov. 27, 2018 (GLOBE NEWSWIRE) -- Zomedica Pharmaceuticals Corp. (NYSE American: ZOM) (TSX-V: ZOM), a veterinary diagnostic and pharmaceutical company, today announced it has entered into a development and supply agreement with Qorvo Biotechnologies, LLC (Qorvo), a wholly-owned subsidiary of Qorvo, Inc. (Nasdaq: QRVO) focused on bringing its piezo-electric Bulk Acoustic Wave (BAW) sensor to the veterinary health sector. Under the terms of this agreement, Zomedica has exclusive, global rights to develop and market Qorvo's investigational point-of-care diagnostic platform for veterinary use.
https://www.qorvo.com/newsroom/news/2018/zomedica-signs-exclusive-agreement-with-qorvo-biotechnologies-for-global-vet-rights-to-point-of-care....”
“I. Introduction
FDA is issuing this guidance document to provide the current thinking of the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) on when in vitro diagnostic (IVD) products1 are properly labeled “for research use only” (RUO) or “for investigational use only” (IUO)2. FDA is concerned that the distribution of unapproved and uncleared IVD products labeled RUO or IUO, but intended for purposes other than research or investigation (for example, for clinical diagnostic use3), has led, in some cases, to the clinical diagnostic use of products with unproven performance characteristics, and with manufacturing controls that are
1 “In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. These products are devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (the act), and may also be biological products subject to section 351 of the Public Health Service Act.” Title 21, Code of Federal Regulations (CFR), section 809.3(a).
2 This guidance is only intended to apply to IVD products that have not been approved, cleared or licensed for any use, and it is not intended to address off-label uses of any approved, cleared or licensed products.
3 Throughout this guidance document, references to “clinical diagnostic use” and “use in clinical diagnosis” include use in making medical treatment decisions.
4
Contains Non-binding Recommendations
inadequate to ensure consistent manufacturing of the finished product. Use of such tests for clinical diagnostic purposes may mislead healthcare providers and cause serious adverse health consequences to patients, who are not aware that they are being diagnosed with or treated based on the results of tests with research or investigational .....” https://www.fda.gov/media/87374/download
Dr. Oz spoke about COVID-19 diarrhea today.
ADOM stock is undervalued and should be in the $20.00+ price range. The reason for the $20.00+ price range is because Adomani manufactures emission free electric vehicles that have been ordered and delivered to customers. Adomani also manufactures electric conversion kits to convert gas engines into electric vehicles. And Adomani also provides component batteries and additional parts for Electric Vehicles. So, Adomani has a complete product line and is also certified safe and approved for New York State in addition to Department of Environmental protection and the state of California.
https://adomanielectric.com/products/
https://adomanielectric.com/about-us/
https://portal.nyserda.ny.gov/servlet/servlet.FileDownload?file=00Pt000000Q4MlCEAV
https://adomanielectric.com/2020/06/30/adomani-applauds-california-air-resources-boards-bold-step-to-reduce-truck-pollution/
Pres. Biden will implement all electric and no fossil fuels.
Crushed resistance @ .46: http://www.stockta.com/cgi-bin/analysis.pl?symb=ADOM&cobrand=&mode=stock
Blew through moving averages. https://www.barchart.com/stocks/quotes/ADOM/technical-analysis
68% Welcome to the beginning.
Up 60% so far.
$20.00 + imminent!
Word is out. Hold. Long Buyers loading. Moon shot.
More ATH!!!! $20.00+ guaranteed.
ATH!!!!!!!
And made in the USA.
ADOMANI® Electric Ramps up for Big Mid-Year Push
https://www.culthub.com/tech/adomani-electric-ramps-up-for-big-mid-year-push/197720
ADOMANI(R) EV Assembly/Service Facility in Corona, California https://adomanielectric.com/2020/02/13/adomanir-opens-ev-assembly-and-service-facility-in-corona-california/
Search link for “ADOMANI:” https://portal.nyserda.ny.gov/servlet/servlet.FileDownload?file=00Pt000000Q4MlCEAV
Search link for “ADOMANI:” https://portal.nyserda.ny.gov/servlet/servlet.FileDownload?file=00Pt000000Q4MlCEAV
Watch the video at 2:13,