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FDA confirmed that studies previously conducted using first

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georgejjl   Tuesday, 02/12/19 08:12:16 PM
Re: georgejjl post# 720
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FDA confirmed that studies previously conducted using first generation ProSavin® may be considered part of a single development program with AXO-Lenti-PD, including the preclinical data and over 10 years of clinical data of ProSavin. The FDA also provided feedback on the design of the SUNRISE-PD phase 2 study of AXO-Lenti-PD and agreed that current manufacturing and quality control plans were adequate for the clinical program.



http://investors.axovant.com/news-releases/news-release-details/axovant-announces-third-fiscal-quarter-2018-financial-results

Good luck and GOD bless,

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