RE: RE: follow up news is not goodTranslation:
“The meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee scheduled for June 28, 2010, is cancelled[NOT POSTPONED, CANCELLED]. This meeting was announced in the Federal Register of May 11, 2010 (75 FR 26264). The meeting was to discuss new drug application (NDA) 22340, voclosporin 10-milligram capsules, by Lux Biosciences Inc. This meeting has been cancelled to allow time for the resolution of several outstanding issues [THERE IS MORE THAN ONE PROBLEM]. The agency intends to continue evaluating NDA 22340 [NOT SERIOUS ENOUGH TO REJECT THE APPLICATION OUT OF HAND, ISSUES MIGHT BE RESOLVABLE]and, as needed, may schedule an advisory committee meeting in the future [BUT, AT BEST, A SIGNIFICANT DELAY - ITS NOT LIKE THEY CAN RESCHEDULE THESE THINGS ON A WEEK'S NOTICE].”
“At this time, the FDA has not communicated all [THERE WERE ALREADY PROBLEMS AND NOW THERE ARE MORE] the outstanding issues to Lux for the uveitis application,” stated Dr. Robert Foster, President and CEO of Isotechnika Pharma. “They await the action letter from the FDA which is expected on or near the PDUFA date [I.E. NOT ENOUGH TIME FOR EVALUATION SO AUGUST 3 IS OUT OF THE QUESTION]of August 3, 2010 for further clarification.”
So bottom line we are still in the running but it will be a few months at earliest and then only IF the problems are not fatal.
This thing will drop like a rock tomorrow. I am guessing it will settle at about 20 cents. I pulled out on the follow up news. Not sure yet if I will come back in.