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Friday, July 20, 2012 2:42:26 AM
TLON..$1.34 The Phase 3 study now under SPA, named HALLMARQ (Halting newly diagnosed Adult acute Lymphoblastic Leukemia with Marqibo containing chemotherapy), is intended to be a confirmatory study to be completed following the accelerated approval of Marqibo. Talon expects to know if the NDA has been accepted for filing by the FDA in mid-September 2011.
A Caveat from Dr. Pazdur In 2005 he (Richard Pazdur) stated: “If there is no available therapy, then a single-arm study with a good response rate might be acceptable. he explained. After accelerated approval, a sponsor must prove clinical benefit by a separate confirmatory trial. The agency would like this trial to be underway before granting accelerated approval.
A Caveat from Dr. Pazdur In 2005 he (Richard Pazdur) stated: “If there is no available therapy, then a single-arm study with a good response rate might be acceptable. he explained. After accelerated approval, a sponsor must prove clinical benefit by a separate confirmatory trial. The agency would like this trial to be underway before granting accelerated approval.
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