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: Dennis Ding - Jefferies - Analyst
: Hi, good morning and thanks for taking a question on maybe on enobosarm and its safety profile. How do you think about the profile of the safety
data that you guys have to date? And how do you think that would translate in obesity and how the FDA will think about the storms and enobosarm
given the risk-benefit profile is much different and in obesity versus in cancer? Thanks.
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Question: Dennis Ding - Jefferies - Analyst
: Got it. Thank you.
Question: Leland Gershell - Oppenheimer & Co., Inc. - Analyst
: Tanks for the update. A couple of questions from commercial. First, with respect to the modified release formulation that you mentioned, you're
you're you're working on enobosarm is a once-daily.
Just wondering beyond the basis for new IP, what might be the clinical advantages of Pobeda modified-release that you're going after? And
secondly, would you expect to take that into a pivotal program in sarcopenia and also with the primary endpoint for the Phase IIb be applicable
to the Phase three, how do you see that any differences in what's required for registration for another arm in circuit being? Thank you.
Question: Leland Gershell - Oppenheimer & Co., Inc. - Analyst
: Thanks. And just curious, in terms of the Phase three design, would you expect that to be replicative of the Phase IIb or any significant differences
required for registration you needed for the Phase three?
Yes, suggested associated with the Phase two/III pivotal to, I think the Phase IIb.
Question: Leland Gershell - Oppenheimer & Co., Inc. - Analyst
: Understood. Thanks very much.
Question: Yi Chen - H.C. Wainwright & Co., LLC - Analyst
: Thank you for taking my question. Just to clarify, so you expect the top-line results of the Phase IIb trial to show that the muscle master remain
roughly the same.
Correct. So clinically speaking, what percentage in in terms of percentage range, what would be considered roughly the same, but Misonix?
So I'm going ask Dr Barnette to answer that question, so Gary?
Question: Yi Chen - H.C. Wainwright & Co., LLC - Analyst
: Yes. Okay. So once these start recruitment patient recruitment for this trial, shall we expect the top line results to be to become available before
the end of 2024.
Question: Yi Chen - H.C. Wainwright & Co., LLC - Analyst
: And the Currently the Company is funded to complete the entire Phase IIb.
Question: Yi Chen - H.C. Wainwright & Co., LLC - Analyst
: Okay. Just one last question. I do think enobosarm monotherapy would be good enough for the sake of panic of our patient population
Question: Yi Chen - H.C. Wainwright & Co., LLC - Analyst
: Well, thank you very much.
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