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jaysolano

08/28/18 2:05 PM

#149860 RE: Daytime_Lantern #149857

There is no FDA deadline

There is a common-sense deadline that if the FDA were to award BIEL or its devices in the Opioid Alternative Innovation Challenge, then they would be slacking-fools in the eyes of the POTUS, the people, and anyone who might benefit from such devices if they had not first performed their review and cleared the devices they decide are winners of this challenge.

"THESE GUYS WIN!! Well, just as soon as we verify the safety and efficacy of the the device."

FDA Commissioner might as well have a "Fire Me" sign on his back. :)

Anyway this is moot discussion. People involved in the Q&A webinar for the challenge basically-nearly-almost said if you're in the challenge and a noteworthy contender with a clearance review pending, that they are going to do what they can to get that done.