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Lilly has now reviewed data from a pre-planned interim analysis of semagacestat studies.
FORBES: Eli Lilly Alzheimer's Drug Made Patients Worse
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This interim analysis showed that, as expected, cognition and the ability to complete activities of daily living of placebo-treated patients worsened.
FORBES: Eli Lilly Alzheimer's Drug Made Patients Worse
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However, Nissen's interim analysis included only 133 patients enrolled in the trial, and will include only 260 when it is finished.
FORBES: Fuzzy Drug Company Math
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Following a positive interim analysis showing that fractional flow-reserve-guided PCI was superior to optimal medical treatment, an independent Data and Safety Monitoring Board (DSMB) has recommended that patient enrollment in the ongoing FAME II trial be stopped.
FORBES: New Enrollment in FAME II Halted After Interim Analysis Shows Benefits of FFR
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That could mean the results are close, but Novartis will have to wait until the trial is finished to file with the FDA. Another expected interim analysis from a second clinical trial will not be made public as was previously planned.
FORBES: Two Wins For Biotech
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As a result of the positive interim analysis, the FAME II independent Data Safety Monitoring Board (DSMB) has recommended investigators stop patient enrollment in this trial as the DSMB considers it unethical to continue to randomize patients to optimal medical therapy (OMT) alone.
FORBES: New Enrollment in FAME II Halted After Interim Analysis Shows Benefits of FFR
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Jude Medical, Inc. (NYSE:STJ), a global medical device company, announced today that an interim analysis of the FAME II trial has found a highly statistically significant reduction in the need for hospital readmission and urgent revascularization when Fractional Flow Reserve (FFR)-guided assessment was used to direct treatment in patients with coronary artery disease.
FORBES: New Enrollment in FAME II Halted After Interim Analysis Shows Benefits of FFR