MEI Pharma, Inc. (NASDAQ:MEIP) Q4 2020 Earnings Conference Call - Final Transcript
Sep 09, 2020 • 05:00 pm ET
Thank you. [Operator Instructions] We have our first question from Stephen. Your line is open.
Yeah. Hey, good afternoon. Thanks for taking the questions, and congrats on a pretty productive quarter. Dan, just kind of curious, so, I think you're now kind of speaking to completing enrollment in TIDAL, first quarter of 2021. I guess where you stand right now? What's the level of confidence in that estimate, just kind of based on the last few months of enrollment that look like? And do you think that completing enrollment in the first quarter of next year would allow you to kind of unblind and top line that trial before the end of calendar '21?
Sure. Hi, Steve. Yeah. So, I'd say, as we said last time, or the -- most recently when -- as we were running TIDAL, our first and foremost goal was to open clinical sites around the world, which we kind of completed by December last year. And then starting in the January, early February timeframe is when we started to see what we thought was a reproducible enrollment rate. And then all that crashed obviously, come March, April, May. I'd say in the last two, two and a half months, the rate of enrollment has now come back to the same level it was pre-COVID and based on that, and sort of our projections on where we need to be on a monthly basis, I think we're pretty comfortable of saying first quarter.
Now of course, we'll have to see if the COVID situation gets worse than that will definitely -- could definitely impact, and -- but as we're sitting here right now, I think we're pretty comfortable saying first quarter next year with the caveats of the COVID situation. In terms of the data, there's really -- because it is now a single arm it was -- as you know, it was two arms, continuous versus intermittent schedule. So, there's really no unblinding per se. Once the last patient is treated as we mentioned the response rate as the primary endpoint will be measured at six months following the last patient treated, it takes about a month to get the data in.
So, sometime in the fall, we expect to have kind of top line data, whether it's completely cleaned at that point or not, is unclear. We're going to work very hard to get the data cleaned through central radiology as we go. And then, of course, we'll have to decide how we topline that data. We don't want to do anything that would jeopardize the review by the FDA. So, we will do our best to communicate whatever information we can at that time, whether it's expectation or what, but we will do our best to convey some message prior to the filing.
Understood. And when you speak to the update in the zanubrutinib combination trial, I guess being kind of mid next year is -- should we anticipate that update to just include