Star Scientific Hunky-Dory with FDA Ruling
April 30th, 2011Star Scientific Inc. (NASDAQ: CIGX) shared gained 10% on the day after the company announced the receipt of notices from the Food and Drug Administration regarding its pending ARIVA-BDL and STONEWALL-BDL modified risk tobacco product applications. The notices from Lawrence Deyton, MD, MSPH, director of the FDA Center for Tobacco Products (CTP), said, Not all tobacco products are currently subject to Chapter IX of the FDCA [Federal Food Drug & Cosmetic Act]. At this time, only cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco are subject to Chapter IX FDCA Section 901(b). Based upon the information in your submission, [ARIVA-BDL and Stonewall-BDL are] not currently subject to Chapter IX requirements.
The company can now proceed with marketing these products following the FDAs determination that Ariva-BDL and Stonewall-BDL tobacco lozenges are not tobacco products that are currently regulated under Chapter IX of the FDCA.
Paul L. Perito, Stars chairman, president and COO, commented, We are pleased to have received a determination from the FDA on Ariva-BDL and Stonewall-BDL.
Tags: Scientific, Star Scientific
For the first time in the 98-year history of the Federal Reserve, its chairman held a news conference after its FOMC policy meeting. So, what was the big news? QE2 will end in June as planned, but as I speculated last week, they will keep the balance sheet steady by continuing to reinvest maturing assets into the debt markets. They will also keep the Fed Feds Rate in the 0.00-0.25% range. Both of these are stimulative to the economy.