Rich Yang
👤 PersonAppearances Over Time
Podcast Appearances
We had finger sticks that the patients did from home.
We had venous blood samples on two in-clinic days.
They had commercially available CGM being worn at the same time.
So we generated a very profound amount of information for the FDA for review.
And Amy's philosophy is to collaborate with the FDA, over-communicate.
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?
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.
So there were no surprises when we submit.
There was no precedence to this, right?
Yeah.
no semiconductor biosensor that's ever been approved, a needle-free intradermal sensor.
So how do you go about that?
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.
Yes, we intend to publish.
And Jared will be speaking at the scientific sessions.
We are applying to present formally.
So hopefully we get accepted.
And so Jared will be speaking on the clinical trial results and the...
The first opportunity where we have Jared speaking on some of the pivotal trial data will be at the DTM conference.
Yes.