Ken, you said you thought the FDA granted Fast Tra
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Posted On: 10/17/2025 9:06:41 AM
Re: KenChowder #158005
Ken, you said you thought the FDA granted Fast Track designation in 2019. Good memory. This is from the 10-K for the fiscal year ended 5/31/25.
Quote:
In November 2018, the Company received FDA approval of its Investigational New Drug (“IND”) submission and subsequently initiated a Phase 1b/2 clinical trial for mTNBC. In May 2019, the FDA granted Fast Track designation for leronlimab for use in combination with carboplatin to treat patients with CCR5+ positive mTNBC.
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