Re: The final events.....
in response to
by
posted on
Jan 25, 2019 11:59AM
Growacet
I do not know for sure if hitting 250 events constitutes a material event. That is part of the reason why I was pressing for a clarification from Sarah.
You wrote: "On top of that....as I recall they're going to keep on dosing beyond 250 events and continue adding to the MACE number during the adjudication phase....going perhaps as high as 270."
That is an interesting statement. I assumed based upon the AGM and Bio-Europe presentations, in which they stated last dosing expected by end of 2018, that hitting 250 events would trigger end of dosing. Recall in the AGM they faced a fork in the road. Continue dosing until 250 events are reached (the slower choice; all 250 events are "on treatment" events), or stop dosing sooner before 250 events but still run trial until 250 events are reached (the faster choice; not all 250 events are "on treatment" events). They opted for the former, in which case end of dosing was implied to occur at 250 events and additional 20 events or so were predicted to occur during the last patient visits and adjudication "off treatment" window to give a final tally of ~270 events. However, that being said, I'm not sure if they are obligated to end dosing at 250. This requires more thought.....
"So I'm wondering if Top-Line by Jan 31st isn't completely out of the cards at this point? Probably a long shot...but who knows. You probably have a better idea that most Bear."
Oh man, you're pulling a Lloyd Christmas on me. Is it completely out of the cards? I can't say that with absolute certainty. However, my understanding is that last patient visits and adjudication will require at minimum 2 months based on company guidance and that database lock is required before data can be analyzed for top-line read out. I find it hard to believe that all of those events have happened without Resverlogix issuing a news release. Plus, anticipation of results is a golden opportunity for share price appreciation and IR working to get the word out. A Phase 3 CVOT imminently reading out top-line data under the radar? Not likely in my opinion. Plus, if top-line was ready this soon I would have expected them to receive a late-breaker clinical trial session at ACC 2019 in March. But they weren't on the list announced this week.
All just my opinion. I am not all knowing. Just overly analytical.
BearDown