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CC: could be only a few short of 24 enrolled in 3-32!Trial design 24 participants so "we've almost
completed enrollment" could translate to 22 to 23 enrolled as of Sept 8 CC Finally, these biopsy trials are notoriously slow recruiting. But in
fact, our recruitment rate over our number of sites is faster than what
our lead PI indicated he would expect. Specifically, in our planning
phase, we were told that if we could open 10 sites for recruitment, we
could achieve our enrollment figures in about 18 months. Due in large
part to resources as well as COVID and site reopening issues, we have
only been able to open 3 to date for enrollment. From the opening of our
first of 3 sites to now is 18 months. As usual, the clinical operations
team has done a great job at exceeding expectations, where we've almost
completed enrollment in the same time period with roughly 1/3 of the
sites. Answer
Unknown Attendee (Attendees) Okay. Third question. Then I'll come back in the queue. On the 332, at the last conference call, there was 11 completed and there were several potentials. Have any of those potentials progressed yet to the biopsy stage? Or are you still screening on 332? Answer Michael Rosol (Executives) Yes. No, we have more. I just -- I debated giving the numbers on those. It becomes kind of an accounting game. And of course, we have to think about when we release the data carefully, both related to kind of breaking the seal of the trial -- usually, you do these at defined time points. And then I don't want to speak too much on the data itself because, one, it's not finalized and validated yet; and 2, we want to eventually publish these data. And so the more you talk about data, the less -- the more difficult it becomes to publish or at least, in principle, you're not supposed to be publishing data that you've discussed in great detail. So anyway, with that said, we have advanced. Some of those patients have been recruited into the trial and imaged and biopsied. So we have more patients. In terms of the buckets, as I mentioned, we need to fill out one more of the pathotype buckets. And then the plan is to look at those data and determine what we have found. Can we discriminate between the 3 pathotypes? Or is it a fibroid, non-fibroid, which is very important. And then we'll look at the correlations of the macrophage number and density across all those subjects with our imaging signal. And the more data we have for that, the better. |
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