Re: A few clarifications from IR

...We Welcome You To The Resverlogix HUB withIn The AGORACOM COMMUNITY!

Dear Agoracom Family,

I want to thank all of you for your patience with us over the past 48 hours and apologize for what was admittedly a botched launch of our new site.

As you can see, we have reverted back to the previous version of the site while we address multiple forum functionality flaws that inexplicably made their way into the launch.

To this end:

1.We have identified 8 fundamental but easily fixable flaws that will be corrected in the coming week, so that you can continue to use the forums exactly as you've been accustomed to.

2.Additionally we will also be implementing a couple of design improvements to "tighten up" the look and feel of the forums.

Sincerely,

George et al

Reply New Message

Prev Message Back To Forum Threaded View Next Message

BearDownAZ

Rank: President [?]

Points: 25003 [?]

Votes: 68 Score: 4.5 [?]

Your Vote:

Please Log In to Vote

Did you know? You can earn activity points by filling your profile with information about yourself (what city you live in, your favorite team, blogs etc.)

Re: A few clarifications from IR

in response to

A few clarifications from IR

BearDownAZ

posted on Mar 06, 2019 10:33AM

I followed up with IR last Friday and received response yesterday. It seems that hitting 250 events is not necessarily the BETonMACE end of trial trigger and that the "adaptive trial" allows them to subjectively end the trial anytime at or after 250. Based on the vague event number updates in the recent corporate presentation, it is possible (I'm not saying likely) that they have already met or exceeded 250 events and could make the call to end dosing and start trial wrap up any day now.

I stated: "I notice that you repeatedly use the phrase "250+ narrow events" when my questions specifically ask about the 250 event goal. Once 250 narrow events are adjudicated, can the trial still continue? In other words, is the trigger for trial completion reaching 250 adjudicated narrow events, or does Resverlogix and the clinical team have the option/discretion to continue dosing after 250 narrow events have been adjudicated?"

Answer from Sarah: "As stated in previous presentations, we have options as BETonMACE is an adaptive trial. The current plan is once we reach 250+ narrow MACE (meaning, 250 at min.) we’ll look to wind down the trial. By the time adjudication is complete, we’ll likely end up with more events past 250."

In other news, coming up on March 19 will be the 1 year anniversary of exceeding full enrollment, at which time all patients will have been dosed for at least 1 year! Of course, those that died or discontinued are excluded. One caveat is that last handful of no more than 25 China patients that enrolled after through end of June 2018.