MyDx Inc. (fka MYDX)

[Bed Bath & Beyonce]

What MYDX Canadian Medical Device Application?

After being reminded of the English language being a wonderful thing and reviewing PR and the 10-K from MYDX, something smells a little fishy.

An excerpt from the PR issued by MYDX on December 14, 2017....

.....today announced it submitted an application and is seeking medical device designation in Canada....

Note in that excerpt how “submitted an application” and “seeking medical device designation” seem to be two different items. Why didn’t the PR specifically say the application was submitted FOR device designation? And why didn’t it say the application was submitted to a specific agency?

The way it is worded, the mention of submitting an application could have been an application for anything....supermarket club membership, a credit card application or just about anything else. In other words two separate things to make it sound like the application was for device designation.


Now, fast-forward to two excerpts from the MYDX 10-K released on April 17, 2018.

MyDx plans to evaluate 510K approval in the US and/or Clinical Device Designation in Canada to leverage its consumer products and the ability of insurance companies to support sales of its smart devices and generate HIPPA compliant crowdsourced data.

Why is the company “evaluating” and “planning” clinical device designation in Canada if it already applied in December 2017?

Also from the same 10-K document.....

On April 1, 2018, the Company verbally agreed to enter into an agreement to appoint Dr. Heiner Dreismann to its business advisory board to assist the Company’s management with evaluating potential merger and acquisition opportunities, developing a plan to secure a medical device designation from Health Canada for CannaDx, and other advice related to the Company’s business.

Why is MYDX “developing a plan to secure a medical device designation from Health Canada” if it already applied for it three and a half months earlier?

Further, why does the excerpt from the 10-K specifically say the plan involves Health Canada and the aforementioned PR from December 2017 does not say it applied to Health Canada?

There’s a huge disconnect here.

It has been said that the application process takes anywhere from 60 to 90 days. It has been 143 days since that PR came out with the news of the “application submission.” And no updates or progress reports in the form of a PR or specific mention in the 10-K?

In that aforementioned 10-K, there are 37 hits on the word “application,” and none of them mention having applied for the Canadian Medical/Clincial device designation. Why would the company mention an application submitted to the United States Patent and Trademark Office on July 3, 2014., but not anything about a Canadian application?

Four matches on the word “Canada” in the aforementioned 10-K. Two are copied and pasted here, the other two mentioned last summer’s ad campaign and Yazbeck going to school there.

So where does it specifically say MYDX actually applied for the Canadian Medical Device designation?