MSB Trading - 2019, page-1129

@DoriansMirror –The fact that the MACE events might happen sooner than expect also kept me upat night when I first read/heard about it so I tried to piece together some points.

1. In the Phase II, MACE events were measured at36 months post treatment

2. In the Phase III, 1^st patient wasdosed in 2014

3. 240 were dosed by July 2016

4. Interim futility analysis of efficacy (and notjust safety, which I think is important) was done in 2017 after the 1^st270 were dosed and MSB passed.

5. In April 2018, the DMC reviewed the data of 465again and were happy for the trial to continue.

6. The primary outcome is “Time to recurrent non-fatal decompensated heartfailure major adverse cardiac events (HF-MACE) that occur prior to the firstterminal cardiac event”. As@treed noted, my interpretation ofthis is that so as long as the ‘time’ to events is longer than the comparator(placebo), it doesn’t matter if a MACE event occurs or the absolute value ofthe time it took to get there.

This did provide mewith some reassurance that (a) the earlier time frame may not necessarily bebad as it could reflect that the control (placebo) group just experienced MACEevents earlier than expected; and (b) almost 40% (40/570) were dosed more than36 months ago (in any event the readout was expected this year, a couple ofmonths may not be a big deal). The fact that they passed the interim analysisis a little be reassuring, although I don’t think it can be relied upon. Giventhe limited information on the April 2018 analysis, I wouldn’t look too muchinto that at all.

Obviously these arejust my thoughts, DYOR, etc…

Be very gratefulfor other interpretations of the above to help me think it through as well.