The FDA announced today that they have cancelled the Advisory Panel set for Monday June 28th. There was no reason cited, however Isotechnika’s priority FDA date is still set for August 3rd. See the press release below:
EDMONTON, Jun 23, 2010 (Canada NewsWire via COMTEX) –Isotechnika Pharma Inc. today announced that the U.S. Food and Drug Administration (FDA) has cancelled the Dermatology and Ophthalmology Drugs Advisory Committee review of partner, Lux Biosciences’, New Drug Application (NDA) for voclosporin on June 28, 2010.
The meeting was originally planned to provide a forum for FDA Advisors to discuss the data included in Lux’s NDA for voclosporin in the treatment of non-infectious uveitis involving the intermediate or posterior segments of the eye. The FDA will continue it’s priority review of the NDA with the PDUFA date of August 3, 2010.
“The review process in Europe is also underway and expected to be completed by the end of February 2011,” stated Dr. Robert Foster, President and CEO of Isotechnika Pharma.
More information on Isotechnika Pharma can be found at www.isotechnika.com or www.SEDAR.com.
This is exactly why I exit these plays early, chalk up another victory to the run-up method. We are dealing with an unpredictable government agency. I sold 75% of my shares before this mornings announcement. I am holding my last 25% and I doubled that position at $.2875. I have another order in for more if the price falls. We are only 6 weeks away from the August 3rd FDA date, and ISA.TO (IPHAF) has demonstrated that it can clearly run to at least $.44 (panel run-up peak). From my entry today @ $.2875, $.44 is a 50%+ gain. Great potential profit for 6 weeks