If we were financed up....
in response to
by
posted on
Nov 01, 2017 11:28AM
As with others, I'm of the opinion that the longer the trial runs....the better the chances for ultimate success.
Just playing with numbers hypothetically let's say that there are 100 patients who enrolled in the trial right at the start.....who would now be enrolled for over 100 weeks. That would mean 50 on RVX-208 and 50 on placebo in this hyptheical scenario. Just guessing off the top of my head I would guess that the event rate over 100 weeks in patients with the required profile...that it would be somewhere around 30% over a 2 year period.
So that would mean 15 expected events based on my completely made up scenario...which I'm using to merely illustrate my point.
And the point is this....if instead of 15 events, let's say there have only been 9....with 8 of them happening in the placebo group.
I do think that the longer the trial goes....that it could very well be that the event rate in the dosed group may be much lower....meaning it would take longer and longer to attain the required number of MAC events....Hopefully nobody in the dosed group is suffering MAC events, and the reason its taking so long for the FA is because all (or the vast majority) of events are happening in the Placebo arm....and that's only half the participants.
But a longer trial means higher cost...and we don't have the $$$, at least not yet....hopefully its coming