RedHill Biopharma excited at FDA positivity on 'potential blockbuster'
Israeli biotech firm RedHill Biopharma (TASE: RDHL) has announced that its RHB-105 combination for the treatment of Helicobacter pylori infection has taken steps closer to approval in the USA.
After a positive meeting with the US Food and Drug Administration (FDA), RedHill expects the planned two-arm confirmatory Phase III study of RHB-105, to start in the second half of 2016.
The company believes that planned trial, along with the successfully completed first Phase III study and data from a supportive PK program, will support a US New Drug Application (NDA).
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