Replies to post #11588 on FDA Plays

[duderino]

Star Scientific, Inc. (Nasdaq: CIGX) announced that on Friday, February19 the company filed an application with the Food & Drug Administration forapproval to market Ariva-BDL(TM) as a "modified risk" tobacco product underthe Family Smoking Prevention and
Tobacco Control Act of 2009.

http://www.bioportfolio.com/news/pdf/33322/Star-Scientific-Files-Application-With-Fda-For-Ariva-bdl-tm-Approval-As.pdf

"Based on all these considerations, FDA has determined that, as a reasonable preliminary timetable, the Agency intends to issue a decision on a MRTP application within 360 days of its receipt by FDA."

http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM191915.pdf

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The company also submitted two applications for approval of dissolvable smokeless tobacco products in 2010: Ariva-BDL™ in February, and Stonewall-BDL™ in June. Less than two weeks remain until the one-year anniversary of Star's first modified risk application to the FDA.

http://www.prnewswire.com/news-releases/star-scientific-files-stonewall-moist-bdl-application-with-fda-for-approval-as-modified-risk-tobacco-product-115099009.html

[Biorunner]

CIGX- I have been looking into this one as well and can't find an FDA date anywhere. Is this because it is a tobacco product? The only other thing I have found on them is that they made some kind of submission to the FDA 2/19/2010 and someone said the FDA gets back to them within 360 days which they say makes that 2/14/2011. Since this is the "Play of the Month" can someone fill in the gaps please????