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AOTI, Inc. (GB:AOTI)
LSE:AOTI
Topical Wound Oxygen Therapy, Sham Control Topical Wound Oxygen
Venous Leg Ulcer (Vlu)
Phase IV
Recruiting
Trial to Evaluate Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic Venous Leg Ulcers
Dec 16, 2024
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does AOTI, Inc. (AOTI) have in its pipeline
AOTI is currently developing the following drugs: Topical Wound Oxygen Therapy, Sham Control Topical Wound Oxygen. These drug candidates are in various stages of clinical development as the company works toward FDA approval.