NR,
Here are some questions that BearDownAZ posted on other board.
"Based on the constantly moving goalines for completion, say now May or June since PR says first half (not first quarter), we could be looking at July to Sept for topline results, quite a push-out from what we expected."
Good time for ANOTHER reminder to folks on the board about order of events and expectations. Trial completion is a subjective term. Timelines may have only shifted a small bit in my opinion. Last I checked, Q1 2019 still occurs in H1 2019. LOL.
1) 250 non-adjudicated events occur, which triggers end of dosing. AGM Sept '18 and BIO-Europe early Nov '18 indicated end of year still expected for this. More recent MD&A, 8th DSMB press release and December Corporate update didn't explicitly comment on end of dosing. They only made vague/subjective H1 2019 trial completion statement. It's pretty clear that 250 events won't happen by end of year anymore; however, 250 events/end of dosing still coming by Feb 2019 is still very likely in my opinion. Some may consider this end of dosing as trial completion, but remember adjudication and potential follow up periods to follow.
2) Adjudication period starts. AGM Sept '18 and BIO-Europe early Nov '18 indicated 2 months for the adjudication period. More recent MD&A and December Corporate indicated 2 to 3 months for adjuciation. Offering a wider range doesn't mean that 2 months isn't still a possibility. This period starts after 250 events have been reached and according to company guidance an additional ~20 events may occur during this adjucation process. My understanding is that these additional 20 events will be during the "off dosing" period and may be treated differently in data analysis since they are no longer "on treatment." Clarification is needed here for how the 20 events are treated and how potential patient follow ups (see below) fit into the mix.
3) Patient follow ups. This is a somewhat vaguely described process. In all of the BETonMACE trial design slides/posters/figures, this end of trial follow up period is listed as 4-16 weeks. But does this follow up period need to occur before adjudication begins? Does this happen concurrent with adjudication? Is this follow period even necessary since BETonMACE trial protocol was amended to allow dosing beyond 104 weeks? Depending on answers to these, the time for combined follow-up and adjucation may be shorter or longer. Perhaps the more recent 2-3 month adjudication guidance accounts for an additional few weeks of follow up on top of the previous 2 month period stated for adjudication?
4) Top-line Results. Expected shortly after completion of adjudication. Assuming 250 events and end of dosing occurs Feb '19, and also assuming a 2-3 month range for combined follow up/adjudication period, then top-line data could still come April or May 2019.
5) Full Results. Lots of conferences in May/June 2019 to potentially present first round of full results that will likely only focus on the primary MACE outcome, in my opinion.
BDAZ
P.S. Of course, everything gets shifted later if 250 events/end of dosing doesn't occur by Feb '19.
