The Sample Size Recalculation Analysis (SSRA) has been in the BETonMACE plan all along. I recall the company discussing back in 2015 around the time of start of BETonMACE that this SSRA would occur at 175 events. Regardless of whether my recollection is accurate, the most recent MD&A stated "a sample size reestimation analysis is planned after 75% of the primary MACE events have been adjudicated," which would put the SSRA at 188 (75% of 250). I recall back in 2015 hearing that the SSRA could result in the number of patients being increased to 3600 and the number of target MACE events being increased to 375. Again, this is just my recollection and may not be accurate or plans may have changed. 

As for the futility analysis, I don't think the company has ever officially stated that the futility analyis is not going to happen. Some shared comments from the AGM Q&A regarding this, but as far as I'm concerned the futility analysis is still going to happen at or before 75% of events as stated in a recent (not the most recent) MD&A. My guess is that the futility analysis and SSRA happen at the same time.

How does the SSRA, futility analysis, potential for more target MACE and more patients, and having USA patients start so late in the game impact the total length of BETonMACE and timing of top-line data release? I touched on that in this post after the AGM last month (see the four scenarios at the bottom). Those are just a few of the potential scenarios in my opinion. As Tada mentioned, it would have been nice to hear more details about how many recruits the FDA wants, and whether there is a minimum length of time for USA patients to be dosed or a minimum number of MACE events needed to be contributed by USA patients to the total MACE count. If the SSRA results in an increase to the number of patients and target MACE events to 3600 patients and 375 MACE events, then obviously it will take longer to finish the trial and the timeline presented in the news release today will be adjusted.

As for scientific news possibilities prior to late 2018......here are a few just off the top of my head: start of renal trial, start of Fabry trial, completing enrollment of renal and Fabry trials, hearing results of SSRA and futility analysis for BETonMACE, completing BETonMACE enrollment (assuming SSRA doesn't increase the number of patients), more publications (DM references 5 are in the works already for 2018). 

BearDownAZ

Hartland wrote: "Ok Bear I'll  bite what the heck is this [Sample Size Recalculation Analysis] .Does this mean that the FA we were waiting for a few months ago is no more?What will be the scientific  news possibilities prior to late 2018?Finance I get but the science adjustments not so much,thx"

Tada wrote: "How many recruits does the FDA want? How many US clinics are on board? Why would the number of recruits need to be increased?"