Rejection of Phase 2 Clinical Trial Plan for COVID-19 Vaccine AdCLD-CoV19-1 LP.8.1
The Ministry of Food and Drug Safety rejected the IND for Phase 2 clinical trial of COVID-19 vaccine AdCLD-CoV19-1 LP.8.1 due to insufficient data.
The company will review the rejection reasons and establish a response plan, including potential appeal.
The statistical probability of final approval for clinical trial drugs is about 10%, indicating commercialization uncertainty.
KOSDAQ Filing Information
Filing: Major Management Matters Related to Investment Decision (Rejection of Application for Approval of Phase 2 Clinical Trial Plan of COVID-19 Preventive Vaccine AdCLD-CoV19-1 LP.8.1 (IND))