Here is why it will be approved. Bupivacaine is already approved for post surgical treatment of pain. This is a formulation change Look at PACIRA PHARMS INC they multiple drugs taken to market with varying formulation of Bupivacaine. DRRX is a buyout target their platform is huge. Insiders are holding18% of the company why you ask because they know what the PPS offer would be once approvals are handed down.
1,060 subjects have been studied in the POSIDUR Phase 2 and 3 clinical development program, of which 668 have been treated with POSIDUR, 268 with SABER-Placebo (SABER vehicle without drug), and 124 with bupivacaine HCl solution. In July 2012, we completed pre-NDA communications with the FDA regarding POSIDUR. Through this process, we have received guidance and thoughtful comments from the FDA covering various chemistry, manufacturing, nonclinical, clinical pharmacology, clinical, statistical and product labeling topics based on our pre-NDA meeting questions.