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7 months ago
BRIEF-22nd Century says FDA provides positive feedback for it's low nicotine MRTPA filings
January 5, 2017 / 2:26 PM / 7 months ago

BRIEF-22nd Century says FDA provides positive feedback for it's low nicotine MRTPA filings

1 Min Read

Jan 5 (Reuters) - 22nd Century Group Inc :

* FDA provides positive and encouraging feedback for 22nd Century's very low nicotine MRTPA filings

* 22nd Century Group - in response to FDA's requests, and in conjunction with additional clarifying guidance, company has withdrawn its existing filings

* 22nd Century - FDA requested more information on independent clinical studies on very low nicotine tobacco on smoking cessation, harm reduction objectives

* 22nd Century Group Inc - has withdrawn its existing filings in order to file even more expansive MRTPAs and PMTAs for Brand A

* 22nd Century Group Inc -intends to bifurcate application into separate PMTAs and MRTPAs for Brand A to enjoy benefit of FDA's shorter review timing Source text for Eikon: Further company coverage:

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