The company said it anticipates this decision based on feedback provided subsequent to a meeting with the agency this week.
Genta can request a re-examination of the initial opinion, including a review by a specialist scientific advisory group. The company will be evaluating whether to pursue this option after receiving additional feedback.
“We believe the safety and efficacy results for Genasense plus dacarbazine are superior to any other product ever considered by regulatory authorities for advanced melanoma, and we remain committed to its development and approval,” said Dr Raymond Warrell Jr, Genta’s CEO.
Genta said if they pursued a review of the opinion that a final opinion could be rendered within approximately four to six months.