(1) As soon as practicable after the department’s notification that a consortium is selected to conduct an ibogaine drug development clinical trial under this chapter, the consortium must enter into an agreement with the lead consortium after the lead consortium, whether acting through an agent or joint venture, has taken both of the following actions:(a) Has submitted an investigational new drug (IND) application to the FDA in accordance with 21 CFR Part 312; and(b) Has requested a breakthrough therapy designation for ibogaine from the FDA under 21 USC Section 356.
(a) Has submitted an investigational new drug (IND) application to the FDA in accordance with 21 CFR Part 312; and
(b) Has requested a breakthrough therapy designation for ibogaine from the FDA under 21 USC Section 356.
(2) The consortium selected by the department shall work with the FDA to coordinate the drug development trial in Mississippi with ibogaine drug development trials that are being conducted by the lead consortium and in other states.