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PATH Corporation (JP:3840)
:3840
Ivt Gbs-06
Group B Streptococcal Infections
Phase I/II
Active Not Recruiting
Phase I/II Study to a Assess the GBS-06 Vaccine Manufactured by Inventprise, Inc., in Healthy, Non-Pregnant, Adult Women of Childbearing Age.
Sep 23, 2024
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Non-Adjuvanted Study Formulation Nmcv-5, Adjuvanted Study Formulation Nmcv-5, Menactra
Meningitis, Meningococcal
Phase II
Completed
Clinical Study of Meningococcal ACYWX Conjugate Vaccine, in 12-16 Month Olds
Sep 20, 2017
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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 PATH Corporation (3840) have in its pipeline
3840 is currently developing the following drugs: Ivt Gbs-06, Non-Adjuvanted Study Formulation Nmcv-5, Adjuvanted Study Formulation Nmcv-5, Menactra. These drug candidates are in various stages of clinical development as the company works toward FDA approval.