http://yahoo.brand.edgar-online.com/disp...

FDA chosen topical application consistant with one used by NeurogesX in trial.

"Preliminary results of Study C123 showed the mean duration of patch application was 60.2 minutes, versus a target duration of Qutenza patch application of 60 minutes. No patients removed the Qutenza patch prematurely (i.e.< 90% of the intended full application time).

The company expects to provide results from Study C123 to the FDA prior to the PDUFA date of August 16, 2009. The impact on the agency’s timing, if any, for an ultimate decision on the NDA is not yet known.

Dr. Jeffrey Tobias, NeurogesX’ Chief Medical Officer commented, “I am grateful to our clinical investigators and the entire NeurogesX team for working together to quickly complete this study. We believe that these results will address the FDA’s questions relating to the use of an FDA-approved topical anesthetic as part of the Qutenza treatment procedure.”

Jim