"Ap pharma also received a CRL with no additional clinical trials in 2010, even to this day they havn't resubmitted NDA. "
Really? From the APPA description of their CRL:
"Dosing System
The FDA expressed concerns relating to A.P. Pharma's two-syringe administration system, including potential issues with the transfer of material from one syringe to the other syringe prior to patient administration, certain components used in the dosing system and the potential risk of improper administration of the drug product.
Chemistry, Manufacturing and Control
The FDA has completed inspections of A.P. Pharma and several of its contract manufacturing facilities. The Agency identified certain deficiencies during these inspections, and satisfactory resolution of these deficiencies will be required for approval.
During the NDA review, the FDA asked that the Company determine if terminal sterilization with gamma irradiation is a feasible approach to enhance the assurance of sterility. A.P. Pharma has subsequently demonstrated that terminal sterilization is feasible, and the FDA has requested the Company change to terminal sterilization prior to approval.
The FDA requested clarification and revision of certain analytical specifications proposed in the Company's NDA.
Clinical
The FDA did not request additional clinical efficacy studies, although the Agency has asked for the re-presentation and re-analysis of select existing Phase 3 clinical trial data.
The FDA requested the Company perform two studies relating to bioavailability and metabolism. A.P. Pharma believes these studies should be of short duration in normal volunteers.
The FDA did not accept the Company's request to waive the requirement for a thorough QT study. A.P. Pharma believes this study should be of short duration in normal volunteers. The Company plans to discuss the design and timing of the study with the FDA. "
That sounds like more than a CMC issue to me. Icount 3 trials, w/o even getting into the syringe issue.
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