BDAZ – Last I heard was the DSMB’s next report would be out around mid March, that’s today. If they are off by a week or so I wont lose any sleep and no one else should either. I am not aware of any pre-defind DSMB review dates.

You asked “what did you mean by “hopefully not hearing from the FDA on the Kidney trial application before the 25th of March”

I have heard from RVX in prior meetings as well as from at least 3 other biotech companies that once their IND is filed or the completion of this Type B meeting with the FDA has happened that the FDA has 30 days to respond to them if there is a problem that needs to be addressed. If there is no response within those 30 days then the results of the meeting or IND application are acceptable the way they are. The 25th of March represents the 30th day after 23 Feb. Worth noting is that the 25th of March is a Saturday so any response would have to be prior to the 25th as I stated.

In my opinion this would be incredibly good news as we would have one division of the FDA accepting RVX208 and then just have to wait for the other division to do the same. Essentially this could be the start of doubling our potential market from where it is today. This is worth getting excited about.

Further information about the steps involved in getting FDA approval can be found at  https://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm

tada