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

Free
Message: The synergy of rosuvastatin (Crestor) with apabetalone

I think it will come down to what the FDA says.  If you look at it from the FDA's point of view, it is a dream drug...except for the 95% confidence level (I am making an assumption that it is purely statistical and not bio markers etc.).  

There was a similar situation with another drug, which failed Primary endpoints by a statistical whisker.  The FDA asked the company to add another Phase 3 trial and the drug passed the statistical hurdles...I forget the name but this was around 2010 or so.

One option for the FDA could be to tell RVX to do an additional Phase 3 trial, with x patients and y MACE events.  This extra trial should be much faster as the drug has been proven to be safe, but I am guessing another 2 years.  

All of which comes back to my original question: Back to the FDA.  And any buyer will want to hear what the FDA says.

Share
New Message
Please login to post a reply