Likelihood of BETonMACE getting FDA/US involvement
posted on
May 30, 2017 01:16PM
Anyone remember this slide below (see text below) from the Annual Meeting/Corporate Update on December 15, 2016 regarding interactions with FDA for BETonMACE? The last bullet point "Updated meeting results and outcomes will be made public as they occur – expected to occur in Q1 2017" makes it sound like Resverlogix expected this to get wrapped up months ago. However, this issue seems to have been repeatedly kicked down the road.
FDA Interactions: Endocrine/Metabolic Division
•Filed for a Type C Meeting late summer 2016
•Series of FDA granted meetings and responses occurred throughout the fall of 2016
•Final submission of full FDA requested immunotox report was filed in late fall 2016
•Immunotox data mirrored previous data results - management is very pleased with the results
•Updated meeting results and outcomes will be made public as they occur – expected to occur in Q1 2017