$Shuttle Pharmaceuticals (SHPH.US)$ It's  coming soon The co...

The company said that the FDA's positive feedback and guidance on its Chemistry, Manufacturing and Controls, and clinical protocol design for Ropidoxuridine provides a pathway to IND application submission in the fourth quarter of 2023 to initiate the Phase 2 clinical trial.

Ropidoxuridine is Shuttle's lead candidate of radiation sensitizer for use in combination with radiation therapy to treat brain tumors, or glioblastoma, a deadly malignancy of the brain with no known cure. Shuttle has received Orphan Drug Designation from the FDA, providing potential marketing exclusivity upon first FDA approval for the disease.