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

Free
Message: We are owed....

Rocketman,

I agree that an update regarding the FDA would be much appreciated. At the Q2 update, we were told that by end of 2016 Resverlogix will have a Type C meeting with the FDA to discuss toxicology issues, go forward carcinogenicity program, adding US BETonMACE study sites and review any outstanding requests from the FDA. DM did mention more recently that the FDA required work (e.g. rodent/animal immunotoxicity experiments) are complete and data has been compiled/analyzed and there were no concerns. We were told that at the time of the FDA meeting that safety data from over 1,000 patients in the BETonMACE trial will be available, additional dose response work, MOA and liver biology work will be complete.

So hopefully the meeting(s) with the FDA will finish up before the AGM/corporate update and will allow Resverlogix to comment further on what is going on with the FDA and US involvement in BETonMACE.

BearDownAZ

Share
New Message
Please login to post a reply