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Re: lasers post# 215674

Tuesday, 07/19/2016 12:41:12 PM

Tuesday, July 19, 2016 12:41:12 PM

Post# of 445452
Thanks much Lasers. It almost seems with the FDA now, they should get such answers in writing. Sounded like they followed the first FDA directions to a T and still got the CRL. If I were them, at this point, I'd want their wishes in writing, as they can always find some reason to reject. This whole issue is crazy...and NH may have indeed been able to resolve w/an agreement on the label for a food warning/info/instructions, as opposed to delay and CRL.

Maz

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