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jaysolano

08/19/18 1:45 PM

#149164 RE: DewmBoom #149160

>expedited review of this application

BIEL PR said was filed traditional, non-expedited?

Someone else posted response from an email where BIEL suggested "3 months" as an ETA for clearance or response.

Why expect <30 day review?
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Vapor09

08/19/18 10:41 PM

#149235 RE: DewmBoom #149160

The FDA review is not ten days late. The FDA has sixty days to ask questions, every question resets the sixty day clock. Soonest we will hear anything is mid September.