According to JN:
"The company is preparing a response to the issues raised by the FDA using existing data from the development program. We do not know when that response will be submitted. Management will also be requesting a meeting with the FDA to discuss response and clarification on the regulatory path forward for Probuphine. The company notes working closely with regulatory counsel and a team of expert advisers to address the FDA’s response to the Probuphine NDA. We do not know when that meeting will take place."