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: Chris Raymond - Raymond James - Analyst
: Maybe just -- I've got a few questions here. So on the IOI cases that were attributed to the host cell protein in the drug, I guess how did you
figure out that that that was the cause host cell protein? And maybe can you give a little more color on how you reconfigured the manufacturing
process and you know maybe FDA's sort of role or a level of being queued in on these plans.
Question: Chris Raymond - Raymond James - Analyst
: Okay. And may and maybe just a quick follow-up. So you know I was surprised that you followed these patients out six months. So nice job
on sort of keeping that under wraps. I think we were only expecting the four-week data. But just, I mean, looking at this, obviously, it's 10
letters gain. I know it's a small end, but you're numerically and again cross-trial comparison caveats all all around that's better than aflibercept
had at six months.
I guess the question is, with the patient -- if you follow these folks out six months, and had a sense of a rescue free rate, if you will, was there
a mechanism to get, BCVA, measures from these patients at that point?
Question: Kelly Breeze - Piper Sandler - Analyst
: Hi, this is [Kelly Breeze] on for Biren. We just had one quick question. I was just curious if you guys were seeing anything in terms of shared
baseline characteristics of the patients who did not have to receive additional anti-VEGF treatment during the entire six month follow-up
period?
Question: Lachlan Hanbury-Brown - William Blair Capital Partners - Analyst
: Congrats on the data. I guess the first question would just be on the sort of total retinal fluid reduction data that you had. It's a relatively new
metric. It seems encouraging but relatively new, so I don't think we have many comps for that.
Do (technical difficulty) showing suggesting (technical difficulty) existing treatments were not clear fluid?
Question: Lachlan Hanbury-Brown - William Blair Capital Partners - Analyst
: Yeah. I think that's great. Hopefully, you can hear me better now. But I guess maybe a second question on durability. Maybe for again Drs
Pearlman and D'Amico. A third of patients going six months seems great.
Maybe could they -- could you guys talk about sort of what you would expect with current agents? I'm not sure if we really have data on
that, but I mean, what would you expect if you were to give one of your current agents how many patients might last six months without
needing re-treatment?
Question: John Wolleben - Citizens JMP - Analyst
: A few for me. I might have missed this, but wondering if you saw -- and I know small numbers, but any dose response relationship on BCVA
or CST reduction?
Question: John Wolleben - Citizens JMP - Analyst
: And then you treated six additional patients with the 2.5 milligram. You have this 5 milligram cohort. Wondering when we could see data
from those two batches of patients.
Question: John Wolleben - Citizens JMP - Analyst
: Okay. And last one for me, you mentioned accelerating enrollment in the Phase 1b/2, wondering kind of what steps you mean there? Is this
just presenting the state to investigators, getting people more excited about the program. Or any anything else you're doing? And then,
what do you think that could mean for potential moving up that read out in the second half of next year?
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