How can company press releases relating to Complete Response
Letters provide insight into the likely approval delay?
Pharma received a Complete Response
Letter on the APF530 NDA in March 2010 and is in the process of preparing a resubmission responsive to the deficiencies listed in the Complete Response
The complete response
letter included additional CMC comments focused on tightening manufacturing parameters and narrowing analytical specifications associated with commercial production.
We are disappointed in the decision because we believed that our June NDA resubmission adequately addressed the concerns raised by the FDA in its February Complete Response
Letter," said Richard W.
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.
25 mg dose of palonosetron achieved a complete response
compared to 57.
A complete response
was defined as peripheral blood with 5 percent or less marrow blasts (immature blood cells) and the normalization of the hemoglobin, platelets and white blood cells lasting at least four weeks.
The increase in complete response
rates when adding ZEVALIN radioimmunotherapy is promising," said Samuel A.
When added to the FCR regimen, lumiliximab demonstrated a 52 percent complete response
(CR) rate in patients who have CLL that was progressing after prior therapy.
Three of these individuals exhibited a complete response
to therapy, 13 exhibited partial responses (tumor shrinkage greater than 50 percent) and six experienced minor responses (tumor shrinkage greater than 25 percent but less than 50 percent).
7%) have demonstrated a clinical response to treatment, including one complete response
and two partial responses.
Three patients demonstrated a complete response
, which is defined as a complete