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Re: F1ash post# 2956

Friday, 04/07/2017 11:03:01 AM

Friday, April 07, 2017 11:03:01 AM

Post# of 21531
You're mistaken. There were/are two parts to Anavex's Phase 2a trial. There is Part a and Part b. Part a was 36 days. Part b was 52 weeks after Part a ended. Part b was extended for an additional two years. Total trial length for Ph 2a if you include the 2 year extension will be 3 years and 36 days.

Anavex's clinical trial designs are what the FDA now desires. They are the FDA's preference. Anavex is wise to design their trials per the FDA's preferences. Many trials fail b/c drug companies don't follow the FDA's advice and preferences.

Did the FDA request and prefer that Neurotrope design their Ph 2b and Ph 3 trials to be only 3 months? Or was it Neurotrope that requested the FDA approve their abbreviated trials? I'm guessing the latter was the case?
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