Anebulo Pharma: FDA Provides Favorable Input On Studies To Support ANEB-001 Approval

(RTTNews) - Anebulo Pharmaceuticals, Inc. (ANEB) announced positive feedback from the FDA following a Type B meeting in July. The company said the FDA indicated that a single well-controlled study of ANEB-001 in ACI patients presenting to the emergency department combined with a larger THC challenge study in volunteers could potentially provide substantial evidence to support a new drug application.

"The encouraging feedback we received from the FDA provides a viable path forward for designing and executing our Phase 3 trials with ANEB-001. Based on this constructive guidance and continuing dialog with the FDA, we are focusing on finalizing our registrational study designs," said Simon Allen, CEO of Anebulo.

Anebulo said it has completed dosing in an open-label Part C extension of its Phase 2 clinical trial to evaluate the safety and efficacy of ANEB-001 at higher challenge doses of THC.

Shares of Anebulo Pharmaceuticals are up 3% in pre-market trade on Monday.

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