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Rich Yang

👤 Person
277 total appearances

Appearances Over Time

Podcast Appearances

Vanguards of Health Care by Bloomberg Intelligence
Biolinq Introduces New Silicon Tech Opens Next Chapter of Glucose and Analyte Detection

We had finger sticks that the patients did from home.

Vanguards of Health Care by Bloomberg Intelligence
Biolinq Introduces New Silicon Tech Opens Next Chapter of Glucose and Analyte Detection

We had venous blood samples on two in-clinic days.

Vanguards of Health Care by Bloomberg Intelligence
Biolinq Introduces New Silicon Tech Opens Next Chapter of Glucose and Analyte Detection

They had commercially available CGM being worn at the same time.

Vanguards of Health Care by Bloomberg Intelligence
Biolinq Introduces New Silicon Tech Opens Next Chapter of Glucose and Analyte Detection

So we generated a very profound amount of information for the FDA for review.

Vanguards of Health Care by Bloomberg Intelligence
Biolinq Introduces New Silicon Tech Opens Next Chapter of Glucose and Analyte Detection

And Amy's philosophy is to collaborate with the FDA, over-communicate.

Vanguards of Health Care by Bloomberg Intelligence
Biolinq Introduces New Silicon Tech Opens Next Chapter of Glucose and Analyte Detection

And so when we did finish and when we did generate our data, by the way, all of the data was blinded to us, right?

Vanguards of Health Care by Bloomberg Intelligence
Biolinq Introduces New Silicon Tech Opens Next Chapter of Glucose and Analyte Detection

But to the data that was generated that we can get in front of the FDA, she actually held pre-sub meetings with the FDA, let them know how we did.

Vanguards of Health Care by Bloomberg Intelligence
Biolinq Introduces New Silicon Tech Opens Next Chapter of Glucose and Analyte Detection

So there were no surprises when we submit.

Vanguards of Health Care by Bloomberg Intelligence
Biolinq Introduces New Silicon Tech Opens Next Chapter of Glucose and Analyte Detection

There was no precedence to this, right?

Vanguards of Health Care by Bloomberg Intelligence
Biolinq Introduces New Silicon Tech Opens Next Chapter of Glucose and Analyte Detection

Yeah.

Vanguards of Health Care by Bloomberg Intelligence
Biolinq Introduces New Silicon Tech Opens Next Chapter of Glucose and Analyte Detection

no semiconductor biosensor that's ever been approved, a needle-free intradermal sensor.

Vanguards of Health Care by Bloomberg Intelligence
Biolinq Introduces New Silicon Tech Opens Next Chapter of Glucose and Analyte Detection

So how do you go about that?

Vanguards of Health Care by Bloomberg Intelligence
Biolinq Introduces New Silicon Tech Opens Next Chapter of Glucose and Analyte Detection

So, and, you know, this is where Amy really excelled in making sure that the FDA was well-informed of every step of the way.

Vanguards of Health Care by Bloomberg Intelligence
Biolinq Introduces New Silicon Tech Opens Next Chapter of Glucose and Analyte Detection

Yes, we intend to publish.

Vanguards of Health Care by Bloomberg Intelligence
Biolinq Introduces New Silicon Tech Opens Next Chapter of Glucose and Analyte Detection

And Jared will be speaking at the scientific sessions.

Vanguards of Health Care by Bloomberg Intelligence
Biolinq Introduces New Silicon Tech Opens Next Chapter of Glucose and Analyte Detection

We are applying to present formally.

Vanguards of Health Care by Bloomberg Intelligence
Biolinq Introduces New Silicon Tech Opens Next Chapter of Glucose and Analyte Detection

So hopefully we get accepted.

Vanguards of Health Care by Bloomberg Intelligence
Biolinq Introduces New Silicon Tech Opens Next Chapter of Glucose and Analyte Detection

And so Jared will be speaking on the clinical trial results and the...

Vanguards of Health Care by Bloomberg Intelligence
Biolinq Introduces New Silicon Tech Opens Next Chapter of Glucose and Analyte Detection

The first opportunity where we have Jared speaking on some of the pivotal trial data will be at the DTM conference.

Vanguards of Health Care by Bloomberg Intelligence
Biolinq Introduces New Silicon Tech Opens Next Chapter of Glucose and Analyte Detection

Yes.