Hartland,

I'm wondering the same things.

It's been 3 months since the 7/25/2017 news release entitled "RESVERLOGIX RECEIVES APPROVAL PATHWAY FROM THE FDA AS TO THE INCLUSION OF USA PATIENTS IN THE PHASE 3 BETONMACE TRIAL" in which Resverlogix stated "Resverlogix has agreed to make adjustments to the existing BETonMACE study protocol and to update the Investigator's Brochure and the Informed Consent Documents." In particular, what changes, if any, might occur to the total enrollment and number of target MACE events that might affect the cost and length of the trial?

On the subject of enrollment, back on 7/10/2017 (prior to the above FDA/US related news release), it was announced that "Total enrollment in the BETonMACE trial is now over 1,600 patients. With the addition of new active clinics in the Territories, and soon in the Netherlands and in Russia, we remain on track for full enrollment in the study by the fall of 2017." And a couple weeks later on 7/25/2017 it was announced that they had exceeded 70% of the 2400 planned patients (at least 1680 patients). And on 8/29/2017, it was announced that "BETonMACE has over 1,750 patients enrolled, representing approximately 75 percent of total planned enrollment." They were adding over a hundred patients per month for a while (Sept 2016 through June 2017), but the numbers announced June-August 2017 suggest that enrollment slowed this summer. I would think that we would now be in peak enrollment stage of the trial, not slowing down. How many USA patients, if any, will be included in BETonMACE? Is 2400 still the target number or is this being increased? Still on track for full enrollment Fall 2017? What is the current enrollment count? 

It's been about a month and a half since we saw in the latest MD&A the statement "The DSMB will conduct additional periodic reviews and a futility analysis is planned after 50-75% of the primary MACE events have been adjudicated." And when asked for a clarification, Clayton offered "The DSMB and the clinical steering committee are in discussions as to the most appropriate timing for the futility analysis, ranging anywhere from 50% to 75% of the events. When a final decision is made it will be announced. The discussions are based solely on statistical analysis factors and not on clinical results." They're really keeping us in the dark here. With that language, it's impossible to know if they've hit 125 events yet. And if we don't know when we've hit 125 events, it's tough to estimate the overall event rate and project how long until we hit 250 events.

As Kelsee pointed out, we have exceeded the previous intervals in between DSMB reports and seems like we might get another any day now. 1st DSMB 8/11/2016; 2nd DSMB 12/5/1016; 3rd DSMB 3/16/2017; 4th DSMB 6/28/2017.

BearDownAZ