Re: The last DSMB update of Feb 26th....
in response to
by
posted on
Jun 27, 2018 09:49AM
Fouremm,
The number of patient years from the longer treatment group is difficult to determine with the info available to me. First patient was dosed November 11, 2015. The first enrollment update was September 12, 2016 with 600 patients reported. The second enrollment update was December 2016 with another 200 patients enrolled for a total of 800. Because of the limited amount of information, there is a 10 month period of uncertainty as to how many of these first 600 patients have already exceeded 104 weeks of dosing. Once September 12, 2018 rolls around in a couple of months, then we can confidently conclude that all of these first 600 patients (minus any deaths or drop outs) are now being dosed beyond 104 weeks.
I agree that knowing the number of adjudicated MACE events so far would be extremely helpful. That is one reason why I am so anxious for the potential SSRA that they may or may not do. It would time stamp the 188 adjudicated event mark.
I am happy that they are dosing past 104 weeks. That will provide safety data for at least some patients for close to a year beyond the original planned dosing period of 2 years.
BearDownAZ