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Re: China Cat Sunflower post# 157309

Monday, 11/05/2018 9:07:26 PM

Monday, November 05, 2018 9:07:26 PM

Post# of 330405
FDA Innovative Challenge

It amazes me that you fall to this trap. It's a big win for BIEL if selected. It is not a matter of accepting them. It's a matter of winning the competition to be in. It is not a trivial thing to be in. It's a huge win. Let's give the event the weight it deserves. This is the FDA.

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