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  • MFDS turns down Jeffty¡¯s integrated Phase II/III trial
  • by Lee, Hye-Kyung | translator Alice Kang | Apr 22, 2025 05:59am
¡°need to conduct a separate Phase II trial¡±
Hyundai Bioscience to decide on strategic response within the 60-day appeal period
The Ministry of Food and Drug Safety has rejected the clinical trial protocol for Hyundai Bioscience's COVID-19 drug Jeffty that the company submitted last year.

According to the minutes of the MFDS's Central Pharmaceutical Affairs Council meeting that was released on the 17th, the council agreed that the integrated Phase II/III clinical trial protocol submitted by Hyundai Bioscience was not valid and that a separate Phase II clinical trial was necessary.

Hyundai Bioscience plans to respect the regulating authority's judgment and comprehensively review the regulatory standards, scientific evidence, and global strategy within 60 days of the appeal period and prepare a response.

During the COVID-19 pandemic, H
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