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60 Degrees Pharmaceuticals Announces Communication From The FDA Of Intention To Respond To Tafenoquine-Babesiosis Trial Protocol Submission In April, 2024

Author: Happy Mohamed | March 14, 2024 08:07am

60 Degrees Pharmaceuticals, Inc., (NASDAQ:SXTP, SXTPW))))) ("60 Degrees Pharmaceuticals" or the "Company"), a pharmaceutical company focused on developing new medicines for infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has communicated its intention to send any comments regarding the Company's babesiosis trial within the month of April, 2024, rather than March, 2024 as anticipated by the Company. The protocol submission mechanism as directed by the FDA, i.e., under the Company's existing (rather than a new) Investigational New Drug application, technically does not require a response from the FDA within a specified time frame.

 

The Company is continuing preparations for a June 1, 2024 start date as previously communicated.

Posted In: SXTP

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