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HLB receives Pre-NDA Meeting Minutes from FDA
HLB announced that Elevar Therapeutics received an official document that recorded Pre-NDA meeting minutes with the FDA after completing Phase 3 of Rivoceranib's global clinical trial. HLB plans to implement the NDA process in earnest based on the contents of this document. A company official said, "The meeting minutes cannot be released since it includes Rivoceranib's detailed strategies for NDA, comparative analysis data to competitors, and etc" and said, "We will fully reflect the comments from the FDA and prepare to proceed with the NDA procedure quickly."
The data needed for the NDA is extensive, including initial studies, nonclinical outcomes such as toxicity and pharmacology, all clinical findings as well as CMC. President Jeon Bok Hwan said, "To save time, CMC, which takes the most time, is steadily preparing data on raw material medicine and finished products through global pharmaceutical manufacturers." It will take months to prepare the documents.
HLB plans to complete the NDA in the first half of next year. A company official said, "Since Rivoceranib is a third-line treatment for gastric cancer that has yet to be cured, it is designated by the FDA as an orphan drug, reducing the screening period to six months." and said, "we will do our best to release the drug next year."