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Wednesday, February 28, 2018 3:10:19 PM
Neurotrope stated in its January 5th PR that:
"Neurotrope is planning a confirmatory study in advanced AD patients not taking memantine as background therapy to evaluate whether the improvements in SIB scores in those patients can be replicated. The company is in discussions with a leading academic institution to design and conduct the trial, which is expected to begin in the first half of 2018.
"Neurotrope's next clinical trial will focus on the 20µg dose, which showed evidence of sustained cognitive improvement in advanced Alzheimer's disease patients," said Dr. Alkon. "It will be designed to confirm, with increased power, the increases in SIB scores observed among memantine-free patients in the recently completed Phase 2 trial. The company has the financial resources required to complete the planned study."
My assumption is that NTRP will request Fast Track status for this confirmatory study. If FDA Fast Track is granted what is the opinion of this board on how the FDA views the significance of Fast Track status.
Does it generally indicate that the FDA sees a higher likelihood for success when Fast Track is granted in a follow up study??
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