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From the Blogosphere
Clolar Decision Aside, Genzyme's Still a Near-Term Sell
<>On Tuesday morning, the FDA's Oncologic Drugs Advisory Committee (ODAC) voted 9 to 3 against the label expansion of Genzyme's (GENZ) leukemia drug, Clolar, in acute myeloid leukemia (AML). The FDA does not have to follow this recommendation, however, it usually does, which suggests that the agency will not likely approve this label expansion in December of this year. This announcement is not surprising given that the published FDA briefing documents indicated concern over the lack of a control-arm in Genzyme's pivotal trial to support this label expansion, along with other questions related>...
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Clolar Decision Aside, Genzyme's Still a Near-Term Sell
<>On Tuesday morning, the FDA's Oncologic Drugs Advisory Committee (ODAC) voted 9 to 3 against the label expansion of Genzyme's (GENZ) leukemia drug, Clolar, in acute myeloid leukemia (AML). The FDA does not have to follow this recommendation, however, it usually does, which suggests that the agency will not likely approve this label expansion in December of this year. This announcement is not surprising given that the published FDA briefing documents indicated concern over the lack of a control-arm in Genzyme's pivotal trial to support this label expansion, along with other questions related>...
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Genzyme: Near Term Sell, Long Term Buy
<>On Tuesday morning, the FDA's Oncologic Drugs Advisory Committee (ODAC) voted 9 to 3 against the label expansion of Genzyme's (GENZ) leukemia drug, Clolar, in acute myeloid leukemia (AML). The FDA does not have to follow this recommendation, however, it usually does, which suggests that the agency will not likely approve this label expansion in December of this year. This announcement is not surprising given that the published FDA briefing documents indicated concern over the lack of a control-arm in Genzyme's pivotal trial to support this label expansion, along with other questions related>...
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Genzyme: Near Term Sell, Long Term Buy
<>On Tuesday morning, the FDA's Oncologic Drugs Advisory Committee (ODAC) voted 9 to 3 against the label expansion of Genzyme's (GENZ) leukemia drug, Clolar, in acute myeloid leukemia (AML). The FDA does not have to follow this recommendation, however, it usually does, which suggests that the agency will not likely approve this label expansion in December of this year. This announcement is not surprising given that the published FDA briefing documents indicated concern over the lack of a control-arm in Genzyme's pivotal trial to support this label expansion, along with other questions related>...
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