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DewmBoom

11/06/18 8:11 AM

#157363 RE: Johnje #157359

Yes. They did call it a winner. When accepted to the challenge among many applicants, it’s a BIG WIN for BIEL. There is something on Facebook that is suggestive of winning, but I don’t think it’s credible yet.
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DewmBoom

11/06/18 8:18 AM

#157367 RE: Johnje #157359

Read this webinar communication by FDA on the INNOVATION CHALLENGE and see how the words accepted or won are interchanged:

Coordinator: Our next question comes from (Rob). Your line is open.
(Rob): Hi. Thank you for taking my call. Question's around eligibility. You
mentioned that medical devices, therapeutic devices, digital health
technologies, and a combination (are those) who'd be applicable for this.
With that said, you listed four different ones there potentially. Is there more
than one winner? Or are you just going to take the best out of those four?

Dr. (Jonathan Jarow): The answer is yes, there will potentially be more than one winner. That's
what we're hoping for. The number of applications accepted in the program
will be limited by both the quality of the applications that we receive as well
as the resources that FDA has at hand to put an all hands on deck approach
with each of these applications that are accepted.

https://www.fda.gov/downloads/Training/CDRHLearn/UCM615733.pdf