Client Wins - Successful Conclusion of a Complex End of Phase 2 Meeting

FDA did not accept several elements of a Phase 3 proposal at an end of Phase 2 meeting where Dr. Gorelick represented the company as the acting CMO. During the meeting, however, we successfully convinced the Agency that there was an urgent need to proceed. As a result of meeting discussions, FDA requested that we schedule 3 follow-up meetings over a 2-month period to address their concerns. Briefing books were submitted in a timely manner and FDA accepted all of the company’s points, including novel surrogate primary and secondary endpoints that Dr. Gorelick had constructed.