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Re: teq0904 post# 48815

Thursday, 07/19/2018 11:27:26 PM

Thursday, July 19, 2018 11:27:26 PM

Post# of 52074
From a Jan 18, 2018 posting on the Medizone site:
"...we now have a clear understanding of the additional testing that we will need to conduct and the additional data that we will need to submit to support our De Novo application. We anticipate being able to perform the additional testing and to provide the additional data within a few months, which would permit us to submit an application for De Novo classification by the end of the third quarter."

This increased understanding came as a result of their meeting with a representative from the FDA. The third quarter would begin in September, if I understand correctly. Not sure how to square that with the timeline you're describing.

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