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Pharma targets resubmission of APF530 NDA in 2012 A.
Men's health

Pharma targets resubmission of APF530 NDA in 2012 A.

Pharma has had two effective meetings with the FDA, that have helped clarify the work had a need to resubmit the APF530 NDA,’ stated John Whelan, A.P. Pharma’s president and chief executive officer. ‘Predicated on our discussions with the FDA and our evaluation of the work remaining, we be prepared to resubmit the APF530 NDA during the first half of 2012.’ At the March meeting, the Company presented information concerning the product dosing system for APF530 and the produce and characterization of APF530. The primary topics discussed with the FDA are explained below: THE BUSINESS proposed replacing its former, two-syringe dosing program with a new, single-syringe system it is rolling out over the past year. THE BUSINESS believes that the new system gives significant safety and comfort advantages over the old system.Of July 12 As, 2012, survival at 6, 9, and 12 months is 64 percent, 46 percent, and 29 percent, respectively. This comes even close to survival of 65 percent, 40 percent, and 31 percent that was reported at the 2012 ASCO Annual Interacting with in June. National In depth Network Guidelines cite historical 12 month survival data of 0-22 percent with solitary agent therapy in this patient inhabitants. Objective tumor responses and stable disease continue being observed in the India trial. Of July 12 As, 2012, 63 patients acquired survived at least 3 months and experienced at least one follow up CAT scan to determine tumor response.