FDA Updates: Alcon, Inc. (NYSE: ACL), NovaBay (AMEX: NBY), Cell Therapeutics (Nasdaq:CTIC)
Below are companies with market caps under $250 million which have either pending FDA decisions or pending clinical trial results that may have a major impact on each of the underlying stock prices. A high risk/reward trading approach to consider for speculative traders is investing a small amount of money that you can afford to lose in a basket of stocks included in Extreme FDA and Clinical Trial Calendar Trades.
A complete list of all headlines and biomedical stock developments can be found on BioMedReports.Com
On 07/06/09 Alcon, Inc. (NYSE: ACL) and its partner, NovaBay Pharmaceuticals, Inc. (NYSE-AMEX: NBY), announced that Alcon has begun treating patients in a Phase 2 clinical trial of NovaBay's patented lead Aganocide(R) compound, NVC-422, for viral conjunctivitis, a type of "pink eye". Conjunctivitis is a pervasive and painful condition that affects both adults and children, leading to more than four million doctor and emergency room visits in the United States each year. NovaBay has a licensing and research collaboration agreement with Alcon, the world's leading eye care company, for use of its Aganocide(R) compounds in the eye, ear and sinus, and in contact lens solutions.
On 07/06/09 Cell Therapeutics, Inc. (Nasdaq: CTIC) announced that it had requested and the EMEA has agreed to an oral explanation in support of the OPAXIO Marketing Authorization Application (MAA) in September, 2009 extending the review for the Committee for Medicinal Products for Human Use (CHMP) opinion on approval until Q4-2009. In April, 2008 the EMEA accepted for review the MAA for OPAXIO for first-line treatment of patients with advanced non-small cell lung cancer who are performance status 2, based on a non-inferior survival and improved side effect profile. The previously scheduled June, 2009 meeting with the EMEA on OPAXIO did not occur due to conflicts in regulatory schedule as CTI focused on completing the pixantrone New Drug Application (NDA) submission in June, 2009.
Biotech investors interested in seeing the complete database of clinical trials and upcoming FDA decisions can access that information here:
http://biomedreports.com/fda-calendar/fda-calendar.html