60 Degrees Pharmaceuticals Announces Communication From The FDA Of Intention To Respond To Tafenoquine-Babesiosis Trial Protocol Submission In April, 2024
Portfolio Pulse from Happy Mohamed
60 Degrees Pharmaceuticals, Inc. (NASDAQ:SXTP, SXTPW) announced the FDA's intention to respond to its babesiosis trial protocol submission in April 2024, a delay from the initially anticipated March 2024. The submission falls under the Company's existing Investigational New Drug application, which does not mandate a response within a specific timeframe. The Company continues to prepare for a June 1, 2024, trial start date.
March 14, 2024 | 12:07 pm
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60 Degrees Pharmaceuticals, Inc. faces a delay in receiving FDA comments on its babesiosis trial protocol, now expected in April 2024. The company continues preparations for a June 2024 trial start.
The delay in FDA feedback might initially concern investors, suggesting potential setbacks. However, since the company continues its preparations for the June 2024 trial start, the impact is neutral. The delay does not indicate a problem with the submission itself but rather a procedural timing issue.
CONFIDENCE 85
IMPORTANCE 75
RELEVANCE 90