...We Welcome You To The Resverlogix HUB withIn The AGORACOM COMMUNITY!

Free
Message: Resverlogix Receives Approval From Health Canada To Proceed With Fabry Disease Clinical Trial With Lead Compound Apabetalone

Prasat on the Investor Village forum asked in a post from today "On a separate note, doesn't anyone else have any concern at all about no FDA yet for this third phase?  I never hear anyone asking why the delay or hold up?"

Prasat....myself and others on this board share your concern. Hopefully 1) we get a corporate update/webcast at the June 19th BIO International presentation; and 2) they address the status of this issue at this presentation/update/webcast.

As posted earlier this week:

Likelihood of BETonMACE getting FDA/US involvement

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

Share
New Message
Please login to post a reply