In the February Complete Response
Letter, the FDA acknowledged objective and subjective efficacy at the beginning and end of treatment in elderly patients, and at the beginning of treatment for non-elderly adult patients, and the most recent Complete Response
Letter did not alter those conclusions," continued Pascoe.
In its Complete Response
letter, FDA asserts that the BEST clinical study, which serves as the pivotal Phase III trial for the application, does not adequately demonstrate efficacy of Gencaro in reducing all-cause mortality in patients with heart failure.
The primary endpoint of the trial was complete response
rate, which was determined by CT scan, the conventional methodology, and PET scan.
A Complete Response
Letter informs companies that an application is not ready for approval.
This complete response
letter has been issued by the US Food and Drug Administration (FDA).
M2 EQUITYBITES-January 22, 2013-Impax Pharmaceuticals gets FDA's complete response
letter for RYTARY's NDA(C)2013 M2 COMMUNICATIONS http://www.
M2 PHARMA-April 27, 2012-US FDA issues Complete Response
Letter to Amgen for XGEVA(C)2012 M2 COMMUNICATIONS
The objective response rate (ORR) was 73 percent, including a 34 percent complete response
(CR) rate, 1 percent partial response (PR) rate, 24 percent marrow CR rate with or without other hematologic improvement (HI) responses, and a 14 percent HI rate.
M2 EQUITYBITES-September 10, 2012-Janssen Research & Development LLC submits complete response
for XARELTO(C)2012 M2 COMMUNICATIONS http://www.
M2 PHARMA-September 6, 2011-Discovery Labs submits Complete Response
to FDA for SURFAXIN(C)2011 M2 COMMUNICATIONS
One complete response
, confirmed to be PET-negative, was deemed by the independent radiologists' assessments to be qualified because the index lesion was in an area that had received prior radiation (a technical protocol violation).
M2 EQUITYBITES-August 2, 2012-Hemispherx Biopharma Inc submits complete response
with the FDA for Ampligen's NDA for Chronic Fatigue Syndrome(C)2012 M2 COMMUNICATIONS http://www.