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eicoman

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eicoman

Re: Bryce Harper post# 27157

Wednesday, 03/22/2017 12:23:48 PM

Wednesday, March 22, 2017 12:23:48 PM

Post# of 30352
Questions answered on 7 day device, from Matt beck:

July 2016
Question 1: When is the new device cold chain coming on board in EU, 2016 ? Answer: New cold chain device is approved and being sold in Europe. Same label as above (18 mo shelf life with 72 hr excursion)

Question 2: Is the USA NDA based on the new cold chain dispenser device, with 7 days out of fridge ? Answer: It will be same as EU 72 hour excursion

The EU labeling will change when Ferring launches, and all partners and all labeling will be updated all at the same time.

Matt Beck
Vice President

The Trout Group LLC
740 Broadway, 9th Floor
New York, NY 10003


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