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Re: 2014shelby post# 50719

Tuesday, 02/18/2020 8:07:16 AM

Tuesday, February 18, 2020 8:07:16 AM

Post# of 55008
“Based on the success of the meeting, the FDA’s public statements at the meeting and in its briefing document published ahead of the meeting, as well as the FDA’s previous guidance about the timing of its reviews of MRTP applications in general, we believe the FDA is likely to reach a decision on our MRTP application sometime in the second quarter of this year.

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