The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Myles Robert Minter - William Blair & Company L.L.C., Research Division - Analyst
: I'm just curious as to the 50% screen-out rate. Is that consistent across all sites in Aria? Or are you seeing some sites that are screening out a huge
amount and others that are incorporating more?
Question: Myles Robert Minter - William Blair & Company L.L.C., Research Division - Analyst
: Yes, makes sense. Let's go on to the next question. This one I get a lot. Obviously, your peers out there sort of putting 11 to 13-point placebo
response rates on the HAM-D17. And you're -- it sounds like you're very confident you're going to get much closer to those historic 6 to 8 points
there. So when you look at your most important mitigators built into the trial, so placebo, reminder scripts, the safer protocol, prior episode MDD
patients, like have you actually done work to quantify on a HAM-D17-point basis, what each of those actually contributes to a placebo response?
Or is it more just a fact of, collectively we're just getting a better, more uniform patient population, and ultimately, that's what's going to get us
into the historic placebo response category?
Question: Myles Robert Minter - William Blair & Company L.L.C., Research Division - Analyst
: Just on the Part B of the 944 2a study. I'm just wondering what the definition of the response required is to be randomized into the withdrawal
portion of that trial, considering the FDA is asking you to do, not only tremor, but also activities of daily life. Is it the composite of both of those
measures on the TETRAS?
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FEBRUARY 28, 2022 / 1:30PM, PRAX.OQ - Q4 2021 Praxis Precision Medicines Inc Earnings Call
Question: Myles Robert Minter - William Blair & Company L.L.C., Research Division - Analyst
: Okay. So it's safe to say that 12 patients will be going into that randomization stage regardless of whether they responded or not? And I think,
judging from what you've previously reported from Part B in the 9 patients, yes, it's like, what, a 40 -- no, higher than that, like a 50% response rate.
So it's safe to say that 12 patients, some responding, some not, randomized? Okay.
Question: Myles Robert Minter - William Blair & Company L.L.C., Research Division - Analyst
: Okay. Cool. And then the final one for me is just I did notice for your earlier-stage pipeline that you are looking to push more towards pediatric
epilepsies, actually solely driving that focus, which I think is great. But can you just talk to a bit more color about that decision? And if you do see
decent data out of the trigeminal neuralgia studies, like is that an indication that you'd proceed with? Or you would just take that data and try and
shape further epilepsy programs out of those assets?
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