Flavin continued, "We remain encouraged by the supportive comments made by AIDAC
committee members in June relative to their positive view of the safety profile of Restanza, the therapeutic need for more effective treatments for CAP and their interest in seeing the company pursue further development.
We will work towards achieving a label that accurately reflects the data from the company's landmark trial, the patient population studied, as well as the guidance to the FDA from the AIDAC
, which met less than three weeks ago.
based its decision in part on the review of clinical evidence from the two largest, comparative Phase 3 clinical trials ever conducted against vancomycin in CDI.
aureus bacteremia and infective endocarditis who spoke at today's AIDAC
meeting was Dr.
On June 2, 2009, the FDA AIDAC
reviewed the Restanza NDA.
Details concerning access to the AIDAC
meeting on Monday are available at: http://www.
Advanced Life Sciences is planning a conference call for the morning of Wednesday, June 3, to discuss the results of the June 2nd AIDAC
Further details pertaining to the AIDAC
meeting will be provided by Advanced Life Sciences upon receipt of additional information from FDA.
will discuss and review Arpida's New Drug Application for iclaprim for the treatment of complicated skin and skin structure infection (cSSSI) caused by gram-positive organisms, including methicillin-resistant Staphylococcus aureus, or MRSA.