Analysts speculated that
might dish the data on its Endeavor IV trial at an analyst meeting on Wednesday, but a statement the company issued Tuesday suggests otherwise.
In a report on June 15, Lazard analyst Alexander Arrow noted the possibility that Medtronic could disclose trial data on its drug-eluting stent at an analyst meeting on June 20. Bundled with data from Endeavor I, II and III trials, the new data will be used to support Medtronic's premarket approval submission to the Food and Drug Administration.
The Lazard report said the timing of the data availability and the data-saturation of the cardiology physician community could lead Medtronic to choose an analyst event to divulge the trial results.
The analyst report noted a couple of reasons for the speculation. First, while the data won't be debated before an FDA advisory panel until September at the earliest, Medtronic said there's no rule that would prevent publicly disclosing the data beforehand. And second, Medtronic previously announced that the meeting would have a different format than all previous analyst meetings.
"Conveniently, there are no major cardiology trade shows between now and September," explained the Lazard report, which pointed to another advantage to presenting at an analyst meeting and not a trade show -- "rival Boston Scientific, whose Taxus stent was the control device in Endeavor IV, would not have the opportunity for immediate rebuttal."
But then again, maybe not. Medtronic issued a statement Tuesday saying that the accumulation and assessment of Endeavor IV clinical trial data is on schedule, but both Medtronic and the core lab remain blinded to the results at this time.
"When preliminary analysis is complete in the next few weeks, Medtronic will release the top-line results, specifically the results of the primary endpoint," according to the statement. The referenced primary endpoint for the Endeavor IV trial is target vessel failure at nine months, while the secondary endpoint is major adverse cardiac events at 30-days.
Lazard closed its June 15 report saying, "Notably, we believe the Endeavor IV data won't be presented at the analyst meeting unless the results are good."
While we may not get any affirmation of positive or negative results on Wednesday, at least it looks like we won't have to wait an indefinite amount of time. The statement Medtronic issued on Tuesday said the company was on track for the aforementioned FDA advisory panel meeting.
An aside, Medtronic announced Monday that the FDA gave premarket approval for its Specify 5-6-5 surgical lead for neurostimulation therapy. It's also awaiting the FDA's premarket approval for its Talent thoracic stent graft system. Perhaps the company will touch on those topics at its meeting Wednesday.
Shares of Medtronic closed Tuesday's session up 0.5% at $52.63.