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Thursday, March 21, 2024 6:32:49 PM
1. We note statements in your proposed disclosure for Item 1 and Note 4 that you believe leronlimab is safe and effective, as well as language implying the existence of “clinical data that supports its safety and efficacy.” As safety and efficacy determinations are within the authority of the U.S. Food and Drug Administration and comparable regulatory bodies, please revise your proposed disclosure to remove language that states or implies that you believe leronlimab is safe and effective or that leronlimab is likely to be found safe and effective. You may contact Jeanne Baker at 202-551-3691 or Terence O'Brien, Branch Chief, at 202-551-3355 if you have questions.
https://www.sec.gov/Archives/edgar/data/1175680/000000000021006508/filename1.pdf
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