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: Rick Miller - Cantor Fitzgerald - Analyst
: Hi, this is Rick Miller on for Kristen. Thanks for taking our questions. We've just got two for you today. Can you give us any colour on when you
would look to meet with the FDA as it relates to the 12 mg and 20 mg cohort readouts? And also, what do you think the bar is on C hemoglobin
and VOC reduction now that there have been changes in the sickle cell space? Thanks.
Question: Rick Miller - Cantor Fitzgerald - Analyst
: That's great thank you for the caller.
Question: Joe Schwartz - Living Partners - Analyst
: Great, thanks very much. I was wondering if you can give us any insight into the types of patients who have been enrolling in Pioneer today, given
the detailed rubric required to identify those who are eligible to enrol involves a number of criteria. I'm just wondering if any particular patterns
are presenting themselves, especially now that the withdrawal of [XRA]. Might be influencing things and then I have a follow up. Thanks. Yes.
Question: Joe Schwartz - Living Partners - Analyst
: Okay, great, thanks. That was going to be my second question, so I appreciate that colour, but maybe I can just ask whether there's a particular
hurdle that the DSMB needs to clear before we can advance to the 20 mg cohort. Can you talk about how that process of evaluation will go with
the DSMB?
Question: Joe Schwartz - Living Partners - Analyst
: Thanks for all the.
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FEBRUARY 25, 2025 / 1:00PM, FULC.OQ - Q4 2024 Fulcrum Therapeutics Inc Earnings Call
Question: Matthew Biegler - Oppenheimer - Analyst
: Hey, good morning guys, thanks for the update. Maybe just a little bit more granularity on the type of data that we're going to be getting first
mid-year and then year-end is it do you think it'll be mature enough to have a readout on any early VSC events mid-year? I mean, I'd imagine you're
probably seeing a pretty high baseline rate of VSC given kind of the sicker new patient population you're enrolling, so maybe just like any details
around kind of what we should expect in terms of the types of data would be super helpful thanks.
Question: Matthew Biegler - Oppenheimer - Analyst
: Awesome looking forward to it thanks.
Yes, thanks so much, Matt.
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FEBRUARY 25, 2025 / 1:00PM, FULC.OQ - Q4 2024 Fulcrum Therapeutics Inc Earnings Call
Question: Edward Tenthoff - Piper Sandler Companies - Analyst
: Great, thank you very much and congrats on the progress. Two quick questions just firstly, when it comes to the enrolment, has the requirement
of HU plus another advanced therapy and the removal of Oxbryta complicated enrolment. At all, or are there's still enough patients who were on
Oxbryta that they meet that enrolment criteria and then secondly, when it comes to sort of the safety assessment that the DSMB is going to be
doing, are there any special things we should be aware of, beyond the standard, that FDA is requiring
Thank you.
Question: Edward Tenthoff - Piper Sandler Companies - Analyst
: Great, thank you very much for all that colour and excited for the data coming up in the middle of this year. Yes.
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