Komipharm, PAX-1 Clinical Trial Application Rejected by Spanish FDA
[Asia Economy Reporter Oh Ju-yeon] Comipharm announced on the 14th that the Spanish Agency of Medicines and Medical Devices (AEMPS) rejected the application for the Phase 2/3 clinical trial plan to evaluate the safety and efficacy of PAX-1 in pneumonia patients caused by the novel coronavirus infection (COVID-19).
Regarding the reason for the rejection, the company explained, "We received 35 supplementary inquiries and requests for data related to the clinical trial application from AEMPS and submitted the relevant responses and materials. However, the clinical trial approval was denied due to insufficient explanations on several items."
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The company stated, "We are immediately establishing a detailed confirmation and response plan regarding the reasons for the rejection, and we plan to review and proceed with supplementing the reasons for the rejection and reapplying to obtain approval."
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