January 2, 2024 email written by the attorney for Black, Boynton, Jasinowski, Malik, Powers and Goldman:
Over the next three months, the Company will be preparing for and undergoing detailed inspections of the contract research organizations (CROs) that managed the trial, the Sponsor, the Trial Master File, a number of individual trial sites selected by the regulator from among the 94 sites that participated in the trial, the GMP facility and manufacturing information. Our clients are heavily involved with that process every step of the way. I will be happy to provide more detail on what that process will entail during today’s call.”
January 4, 2024 email written by the attorney for Black, Boynton, Jasinowski, Malik, Powers and Goldman:
“I have also received confirmation that all of the Company’s senior management, including Ms. Powers and Mr. Goldman, will be devoting substantially all of their time to the inspection process over the next three months.”