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

Free
Message: Just back from IR,...

"With positive announcement on Nov 16, RVX still must submitt a request for approval.  Will take time.  In May of 2018, FDA stated if Phase III is favorable, they will grant a license.  Not sure, hopefully this means a fast track."

I think this is the news release that you are referring to. FDA gave positive feedback that a successful BETonMACE would be supportive of a NDA filing to be considered for approval. No guarantee of approval and no guarantee of fast track. FDA would never guarantee approval prior to trial completion and NDA review.

"Does any one know if Lipitor was used in the Australia Phase IIb study.  I do not recall.  After the six month study, the results were off the chart.  We were all waiting for the same result. It appears combining Lipitor with RVX is detrimental to our health."

I'm not sure which trial that you are referring to. Both SUSTAIN and ASSURE were 6 month trials and both included patients on lipitor and crestor. But neither lists Australia study sites on ClinicalTrials.gov. 

Share
New Message
Please login to post a reply