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From what I have read the MYDX analyzer already has both FCC and CE certification, which should provide a great starting point for the medical device classification.
MYDX.DEMURRER/MOTION.TO.STRIKE.OFF.CALENDAR.AS.OF.THIS.MORNING
FYI: $235,000 of stock value changed hands yesterday, over 56 million shares, I am guessing investors want in MYDX.
Recent MYDX press Releases:
https://ir.mydxlife.com/press-releases/detail/68/mydx-seeks-medical-device-designation-for-cannadx-and-the
Press Releases
Home / Investors / Press Releases
MyDx Seeks Medical Device Designation For CannaDx And The ECOSmartPen
Download as PDF
December 14, 2017
Making MyDx Smart Devices More Affordable & Accessible for Canadian Cannabis Users
SAN DIEGO, Dec. 14, 2017 /PRNewswire/ -- MyDx, Inc. (OTC: MYDX), a science and technology company and creator of MyDx® (My Diagnostic), the first multi-use handheld chemical analyzer designed for Cannabis professionals and retail consumers to correlate the chemical profile of cannabis with how it makes them feel and which ailments it alleviates, today announced it submitted an application and is seeking medical device designation in Canada for its CannaDxTM Handheld Tester and its ECOSmartPenTM in order to make its products more accessible to medicinal users seeking to track and manage their consumption habits and prevent abuse.
According to the Institute of Health Economics, under the Food and Drugs Act, medical devices have a broad definition that includes any item sold to diagnose, treat, mitigate, or prevent a disease, disorder or abnormal physical state, or any of their symptoms.
MyDx products will be used to track crowdsourced herbal medicine by our customers to treat various ailments as well as monitor and track consumption habits (a feature shared by both the ECOSmartPen and the CannaDx Handheld Tester) to promote public safety and accountability. It's easy to see how MyDx products can fit within the confines of that description and the company is confident in its ability to gain approval. Still, there can be no assurance that it will gain or be granted such certifications.
Increases Affordability & Accessibility to MyDx Products Country-wide
Recently, Loblaws, a large Canadian supermarket chain, extended coverage for medical marijuana to its ~45,000 employees under policies managed by Manulife and Great-West Life. With a medical device classification, medicinal users would be able to seek reimbursement from their insurance providers for their MyDx devices, significantly lowering the overall cost to patients.
With the advent of new Health Canada Regulations in 2015, following the Supreme Court's ruling that users of medical marijuana should be permitted to consume the product in more varied forms than smoking dried buds, the demand for insurers to cover medical marijuana under benefit plans has increased exponentially according to a report done by Miller Thompson LLP. As a result, the country is beginning to see a shift in its healthcare landscape, which is becoming more marijuana friendly.
"Our goal is enable a more personalized medical experience for every patient by ensuring everyone has access to our smart devices and crowdsourced formulations," said Daniel Yazbeck, CEO of MyDx. "Our products are used all over the world today to help people Trust & Verify® their cannabis and to monitor and track their consumption habits."
Entry level MyDx Handheld Testers currently retail for $699 (plus tax & shipping). The EcoSmartPen is projected to be shipped in the first quarter of next year and the company is currently taking pre-orders on its website at www.mydxlife.com/ecosmartpen.
To learn more about the industry and MyDx, please visit www.meetmydx.com.
About MyDx, Inc.
MyDx, Inc. (OTC:MYDX) is a chemical detection and sensor technology company based in San Diego, California whose mission is to help people Trust & Verify® what they put into their minds and bodies. The Company's first product, MyDx®, also known as "My Diagnostic", is a patented multiuse hand-held chemical analyzer designed to help consumers and professional test for pesticides in food, chemicals in water, toxins in the air, and the safety and potency of cannabis samples, which is the initial focus of through the CannaDxTM application. CannaDx users have submitted over 40,000 crowdsourced datapoints revealing the chemical profile of the cannabis they are consuming and how its making them feel which feeds a data analytics platform, a SaaS business, as well as the biopharmaceutical division of MyDx. The company is committed to addressing areas of critical national need to promote public safety, transparency and regulation in the various markets we serve and hence its more immediate mission is to continue to develop smart devices as part of an ecosystem that crowdsources consumer generated preclinical data to drive innovation in the cannabis industry. For more information, please visit www.mydxlife.com.
ANOTHER POST:-----------------------------------------------------------
This is.the.beginning of.something.huge. I.was.hoping in my lifetime something like this would happen with MYDX and it could happen in 5 years or less!
Ok, months back(references to follow) I suggested how human Genomics are important because it is what MYDX has been saying all along, that each individual physiology is unique and so is how each physiology reacts to same cannabis strain. Phylos fits in perfect with the concept of cross referencing CannaDX sample test data with Phylos cannabis Genomics and now a feeling can be associated with a degree of accuracy to a specific cannabis genome, so now, the individual, not even knowing his/own gene sequence can identify with a specific cannabis plant for a specific ailment relief.
This cross-referencing of data makes each entity(Phylos and MYDX) codependent for generating even more meaningful data to offer the market place. This is the next step in the ultimate cost-effective human/cannabis genome project for medicinal purposes.
I’m not sure what he next step after this would be but eventually, hopefully in my lifetime as well MYDX will be involved in cross-referencing individual Genomics with cannabis Genomics where the individual would know with absolute certainty based on historical data what cannabis product to purchase to remedy a specific ailment or to provide a wanted reaction.
“Phylos uses genome sequencing technology to generate DNA “barcodes” that uniquely identify cannabis varieties. This information is important for basic scientific research, and it also serves as proof of existence that can be used to defend against attempts at patenting.”
http://www.phylosbioscience.com/about/data-policy/
Perhaps this can be used to fight of GW attempts at CBD patenting.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=133208585
“Last year, the China Food and Drug Administration approved the sequencer as a medical device, allowing its use in clinical genetic testing...”
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=132234994
http://www.prnewswire.com/news-releases/pharma-and-biotech-companies-significantly-investing-in-rd-focus-on-rising-demand-for-advanced-medicines-628164013.html Wow, according to this, est. 50Billion dollars is used by these companies alone are using on R&D investments specifically in "advanced medicine" alone:
"In just over a year ago, it's been estimated $50 billion was invested on pharmaceutical Research and Development activities majorly on oncology, diabetes, and autoimmune therapy classes, which is expected to propel the biotechnology services outsourcing market growth. Biotechnology and Pharmaceutical Companies with developments and recent market activity this week include: Moleculin Biotech, Inc., (NASDAQ: MBRX), XBiotech Inc. (NASDAQ: XBIT), GTx, Inc. (NASDAQ: GTXI), Agenus Inc. (NASDAQ: AGEN) and TrovaGene Inc. (NASDAQ: TROV)"
How many of these companies are applying research to the use of medicinal cannabis in the rising medicinal cannabis market? They are clearly focusing their attention on non-cannabis markets and will go through MYDX when the time is right for them which is most likely when medicinal cannabis is legal at the federal level. The more years, the more they will have to pay for all of MYDX's R&D investments in advanced medicinal cannabis vape pen. What effect will this have on current MYDX investors?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=132627843
MYDX is the solution to an EXPOSED PROBLEM: unsafe black market weed. Before it was just black market weed, this by itself is not effective for MYDX but now that it's UNREGULATED HARMFUL BLACK MARKET WEED, the only chance consumers have of not being harmed by illegal unregulated weed is the MYDX CannaDX chemical analyzer with proven successful results! Once MYDX becomes PREMIER HOUSEHOLD CANNABIS QUALITY CONTROL backed by consumers and consumer confidence, what other companies will be around to compete? What direct competition does MYDX have?
MYDX major reasons why MYDX data is so valuable (followed by reference link):
"However, as MyDx began to analyze the data it accumulated from its testing devices, a much darker picture appeared - you cannot trust what dispensaries sell you."
"Today, if you were to go into any dispensary and ask for "Blue Dream", what do you think you would get? Would you get "Blue Dream"?
According to MyDx data, the answer is unequivocally NO!
Unfortunately, not all Blue Dreams are created equal, unveiling the biggest lie in cannabis. Whereas consumer products outside of cannabis enjoy a higher level of consistency and reliability brought on by stricter enforcement of consumer laws, the same cannot be said about the cannabis industry."
"Fortunately for MyDx users, brand names take a back seat to chemical profiles as MyDx tracks data based on sensory responses, interpreted chemical profiles, and an associated feeling or relief. So while you can't trust the brand name you purchase, you can Trust and Verify® chemical profiles and track how those profiles make you feel using MyDx, which has created another opportunity: green Active Pharmaceuticals Ingredients (gAPI)
"I believe extraction and formulation into a concentrate that can be delivered consistently to help patients find relief for their ailments and symptoms is the next logical step to achieving some level of consistency in the industry," stated Daniel Yazbeck, Chief Executive Officer of MyDx."
http://ir.cdxlife.com/press-releases/detail/59/a-problematic-truth-and-a-solution-in-the-making
MYDX Why gAPI is so valuable (link reference to follow):
"...we are now identifying the specific green Active Pharmaceutical Ingredients (gAPI) that can be derived from cannabis, as well as the dosage of each ingredient that should go into a formulation so it can be tailored for a specific therapy. This information not only supports an active engaged community, but also provides the basis for our Company to partner, sell and supply smart devices and formulations to the various communities we service so they can benefit from tailored cannabis therapies that meet their specific needs."
http://ir.cdxlife.com/press-releases/detail/59/a-problematic-truth-and-a-solution-in-the-making
MYDX is HIPPA compliant, important? You be the judge after considering the following (reference links to follow):
"We are finally getting to the heart of what ailments people are tracking and more importantly, what unique chemicals profiles are helping them find relief," stated Yazbeck. "By mining this HIPPA Compliant Data, we are now identifying the specific green Active Pharmaceutical Ingredients (gAPI) that can be derived from cannabis, as well as the dosage of each ingredient that should go into a formulation so it can be tailored for a specific therapy."
http://ir.cdxlife.com/press-releases/detail/59/a-problematic-truth-and-a-solution-in-the-making
Is HIPPA compliance important (reference link to follow)?
"When dealing with patient ePHI, having a HIPAA compliant provider offers practitioners multiple benefits and peace of mind against impending audits."
http://blog.corespace.com/the-benefits-of-a-hipaa-compliant-provider
Is this product helping consumers determine whether or not they want to smoke a certain strain of cannabis before they smoke it? Is this product helping consumers communicate with MYDX verification that a certain strain could have a certain effect for someone interested in similar results as research before they invest in a cannabis purchase? The answer to these quintessential questions is undoubtedly YES and this is what I love about MYDX and what it is doing for consumers through CannaDX. Big deal if someone tells me a certain strain works for them, I want to be able to test it for myself. MYDX will allow me to test a strain I've had that made me feel sick and caused vomiting and dizziness. I love that I will be able to test what strain that was so I know through the "trust and verify" process that I will never put that strain in my body ever again! This is just cannabis, MYDX is so much more but what it accomplishes is exactly what it set out to do from day one and that is allow consumers the opportunity to "trust and verify" something before they expose it to their bodies, and as far as AeroDX, I believe, there will be sensors you can place in a room that will monitor the air so that before someone enters it, they will be able to know if the air is toxic. For sure, if a room's air is toxic after you enter it, AeroDX will let you know. If someone hates this product or company, it can't be for these reasons, so that's what I will never understand about people who say they hate this company and products. I'm not going to ask questions leading to the conclusion that people involved in companies such as big pharma just don't want MYDX to succeed because it is a threat to their market share in their industry.
Two more additional items that could effect the pps coming up are the Demurrer for mydx's lawsuit is tomorrow Dec 15th and on Dec 31,2017 the option of a stock reverse split expires per the sec paperwork that MYDX filed.
2.5 million shares just got ate up at .0042 - we're going much higher today!
MYDX will have $29 million for advertising since they are going to win their lawsuit - count on it!
I saw all the names also that were identified in the Court Documents that MYDX filed in the Superior Court of Ca. also. I personally am very glad MYDX is sticking up for it's company and the shareholders, and we will let the Legal system decide what laws were Violated and what the penalties will be. I would like my settlement as a shareholder in large bills please!!
I have read enough of the 301 pages of MYDX's amended lawsuit filed in the Superior Court of Ca. to make an informed unbiased opinion for ME that MYDX WILL WIN THEIR LAWSUIT. Anyone can purchase it and make their own decision.
Mydx's amended complaint on their lawsuit filed on 11/21/17 in the Superior Court of Ca, County of San Diego is three hundred one (301) pages LONG. IMO, they have probably named the other defendants in the lawsuit, and have supplied all the PROOF needed for their lawsuit. Also, the reverse split option that was announced at the beginning of 2017 expires on Dec 31,2017 per MYDX's SEC papers that were filed, the reverse split has never taken place currently, Mr. Yazbeck said in an interview this year he saw no reason that a reverse split was needed currently. I believe come Jan 1, 2018 with the reverse split option totally gone and OFF the table the pps will be rewarded.
MYDX.LAWSUIT.DEMURRER.STARTS.DEC.15th.IN.SAN.DIEGO.CA.SUPERIOR.COURT
FYI: New article on MYDX:
http://mmjreporter.com/mydx-inc-otcmktsmydx-updates-on-the-ecosmartpen-preorders-32673.html
IMO MYDX will WIN this lawsuit with at least the $29 million judgement. MYDX's attorney firm 'The WEBB Group' has a very impressive win record. A very serious question to the long MYDX stock holders need to start considering is how are you going to want your share of the stockholders judgement - in small or large bills?
Demurrer for MYDX lawsuit to start on Dec 15th(10 business days from now), in the Superior Court of California, County of San Diego. Per County of San Diego Court records currently I noticed that MYDX CEO "Amended Complaint(1st)" filed by CDx Inc: Yazbeck, Daniel: Refers to Dewald,Jerome; Sanzeri,Skip on 11/21/17(this must have been posted recently because I did not see this on Friday). Could it be that MYDX is naming the other 25 defendants in the lawsuit? IMO this is the beginning of the end for the defendants. IMO MYDX will win this lawsuit just like they won the only other lawsuit they have filed in the past. LET THE GAMES BEGIN!!
I'm in no RUSH. I don't care where the pps gets to right now. If it comes down to the .002+ range I am ready to buy in an additional 5 million more shares. Currently at 65+ million shares and still accumulating. BRING IT ON! I got all the time in the world. My original buy in is at .0021 range so I will never loose money with mydx.
MYDX CLOSED GREEN.
Mydx is by far the best MJ INVESTMENT stock to own - it is not a trading stock. MYDX has real products out and more to come.
I AND MANY STOCKHOLDERS CARE ABOUT ALL THE NEW PRODUCTS THAT COMING OUT!!
Once MYDX starts shipping the ECO Smart pen worldwide - this will be HUGE.
MYDX Smart Pen Will Be Popular for a Long Time
MYDX ECO SMART PEN news is on Ameritrade now and looks like PR Newswire is distributing it to their usual 200 media sites worldwide.
We'll I'm in at break even at .00205. MYDX will run a lot higher in the future - you got to play to win.
13.5 million bid at .0032, somebody wants a few shares.
MYDX.LAWSUIT.DEFENDANT.JEROME.DEWALD.CONVICTED.FELON.What are your thoughts about this?
You could be right, Dewald and Sanzeri could settle with MYDX before any trial.
MYDX is not 'phishing' any more - they have FOUND who to blame for the poor stock performance and it will all come out in court!!
I know they increased the O/S count - I bought 65+ million shares of them. We are going to have a big party some day!
Highlander,JEROME.DEWALD.CONVICTED.FELON.WHAT.ARE.YOUR.THOUGHTS?
I am only stating FACTS, that Dewald is a convicted FELON. I do not know about Skip's background - YET!
Some more DD on our friend Jerome Dewald - Defendant in MYDX lawsuit.
A. Factual background
During the 2000 presidential election, Dewald established and operated two political action committees (PACs), one called “Friends for a Democratic White House” and the other called “Swing States for a GOP White House.” Dewald, under the pretense of soliciting campaign funds for each PAC, mailed fundraising letters to political donors whose names and addresses appeared on donor lists maintained by the Federal Election Commission.
The PACs collected approximately $750,000 in contributions, but Dewald paid less than 20 percent of that amount to the political parties or to any outside PACs. He instead funneled most of the campaign donations into his own for-profit corporation that provided “consulting and administrative services” to each of the two PACs. The money ultimately flowed into a bank account maintained by Dewald’s consulting firm, or was seized by the State in conjunction with the underlying criminal investigation.
http://www.opn.ca6.uscourts.gov/opinions.pdf/14a0063p-06.pdf
I agree the motion is to be heard on Dec 15th, and there's a big difference between the reputation of Defendant Jerome Dewald(CONVICTED FELON AND MORE) and the reputation of Daniel Yazbeck(CEO of MYDX). I am sure that his past will come into play at the hearing, you do have to acknowledge if you have ever been convicted of a felony in court(part of procedure). I am a betting person and I am sure glad that I am betting on MYDX to WIN here.
Dec 15th is when the demurrer takes place in the Superior Court of California(remember).
So the defendant Jerome Dewald in the MYDX lawsuit is a CONVICTED FELON? Things might not be going to well after all.
If Mr. Dewald's reputation is a basis of how things are going to turn out - things are looking really bad for Mr. Dewald!
Just some DD on Dewald that MYDX has as a defendant on the lawsuit.
In 2005, Dewald was convicted of felony fraud and larceny charges in Michigan for his role in two PACs he started during the 2000 presidential campaign. The case went all the way to the Michigan Supreme Court, which ruled against him. Dewald eventually filed a habeas petition in federal court. While a district court ruled in his favor, the Sixth Circuit Court of Appeals reversed that ruling in a two-to-one decision.
At the time, sources raised the issue of his past conviction impacting his credibility. Some who were involved with the campaign felt blindsided by the information and distanced themselves from the effort after learning about it.
“Dewald simply used the 2000 presidential election to create an air of legitimacy for his illegitimate objective: to funnel money to his for-profit consulting firm under false pretenses,” wrote Judge Ronald Gilman in an opinion for the Sixth Circuit.
Dewald had created two PACs—one that ostensibly was raising money for the Gore campaign and another for the Bush campaign. Three individuals who donated money to his PACs testified at trial that they thought their donations would be going to the Gore and Bush campaigns directly. They said they would not have donated if they knew the money was not going straight to the campaigns, according to court documents.
Highlander you are saying that some of the John Does are in Korea, Russia and Nigeria. Please provide proof that you are saying some of the defendants are out of the United States. Have you had contact with them?
What are your thoughts about this?
I think WALDO got it.
I'm glad I could give you a laugh, we all need one sometimes, BUT we will see who will have the last laugh when MYDX WINS the court case decided by the Superior Court of California. To me any attorney that is defending a client and they can't even put their address on a LEGAL document is lacking something. Maybe just an oops on their part, I would think their client hopes they don't make too many oops'. December 15 - just around the corner.
Your opinion no case - MYDX, Attorneys and Shareholders say oh yes there is a case and BRING IT ON. The Judge will decide who is right.
BRING IT ON!! MYDX HAS NOTHING TO HIDE!!