Torpedoman.....thanks for your notes from the AGM. Regarding patient recruiting and futility study.......

Back at Rodman & Renshaw, DM said they were about a quarter enrolled and estimated that they should be over 1000 patients by end of year. They are aiming for 3600 patient years (2400 patients with avg treatment for 18 months). Torpedoman noted that in the AGM Q&A, DM said that recruitement is about 1/3 of the way through. And during the webcast, DM mentioned that the recruitment is a little behind. This triggered a clause to bring in Russia (20 sites, 200 patients) as another country. This will be paid for by the contract research organization. Additionally, Taiwan will begin recruiting in Q1. Long story short, recruitment is running behind original estimates.

How does this impact the timing of the 125 MACE event triggered futility study? Early estimates were "mid-year" 2017. At the 10/16/16 R&D update, Sweeney said H2 2017 and DM said H1 2017. The number of events is a factor of number of patients and event rate. Assuming the anticated event rate is the same as original estimates, then a lag in patient recruitment would likely mean a delay in hitting the 125 event target. I'm also surprised that DM mentioned, according to Torpedoman, that they know when there is a MACE event. My guess is that if RVX does know about a MACE event, that they are blinded as to whether it is placebo or apabetalone. That info is likely only known by the DSMB.

It sure would be nice to have the fulility analysis done before 8/28/17 when the loan s due for re-payment. Regardless of when the futility analysis happens though, the most important thing is that the futility analysis yields positive results. I'm starting to think that Sweeney's H2 2017 comment at the R&D update is the more likely outcome. Assuming that the completion of the futility analysis is a key milestone for big pharma to really get interested, as Tada suggested, then Torpedoman may lose out on that rum bet that had a June 30th deadline. :-)

BearDownAZ