In both events ( slide 15 Rodman & Renshaw 9/10/15 & slide 35 Resverlogix update 9/29/15) both just peg the number of MACE events at 250. But they don't elaborate as to why the number 250 was chosen. Why not 200 or why not 300. Is there a rule of thumb they go by in picking a number based on the number of trial participants? If you know. 

More is said about the 250 events needed is in the Q & A in the Resverlogix's update:

"Q: Hi Good afternoon. I’m going to ask a question about the clinical trial period. It’s a period estimated to be two years, one hundred and four weeks. Is that something by design, something particular to you, something you’ve been advised by the FDA? I’m curious about the background.

A: It’s an event-driven trial. So looking at the background rate in previous studies of the number of MACE events, we realized that we required 250 of them, and the average exposure to gain this based on previous studies is eighteen months So if you then have a year, year and a half to recruit the patients it comes to two or two-and-a-half or three years. So it’s actually designed as to include the period that we feel that we need to have the 250 events."

However the answer is not all that clear to me at least anyways.

On another note, slide 15 in the R&R  presentation it states the following,

'The first patient will stay on-drug until they have completed two years, and the last patient enrolled will stay until they have been on-drug for twelve months. Therefore, we’re estimating that the average will be about 18 months on drug."

So late entries past June 2018 will continue dosing until June 2019 and so on. We have been told however that dosing continued past Dec 2018. So will late entries be counted in the overall scheme of things, hence causing a delay in the reporting of the data? 

Koo