Ua hoʻolaha mua ka hui ma ʻOkakopa 20, 2021 i kahi paʻa lapaʻau i kau ʻia ma ke aʻo ʻana e ka FDA. Ua hāʻawi ka Hui i kahi mea hou e pili ana i ka mea ma Nowemapa 18, 2021 a waiho i kahi hoʻololi i ka FDA no ka noi noiʻi Investigational New Drug (IND) ma Dekemaba 9, 2021. Ma o ka leka i loaʻa i kēia pule, ua wehe ka FDA i ka paʻa lapaʻau a ʻōlelo aku. Tryp hiki ke hoʻomau i ke aʻo ʻana.
Ma ka ʻōlelo ʻana e pili ana i ka hoʻomohala ʻana, ua ʻōlelo ka Pelekikena a me Luna Nui ʻo Greg McKee, "Ua hauʻoli mākou e neʻe i mua me kā mākou Phase 2a hoʻokolohua lapaʻau i ka maʻi ʻai binge ma o kā mākou hui pū ʻana me ke Kulanui o Florida. ʻO kā mākou kamaʻilio me ka FDA ua huahua a ua hoʻomaikaʻi maikaʻi i ka hoʻolālā ʻana o kēia haʻawina. Hōʻike kēia i ka noiʻi lapaʻau lua ma 2021 i loaʻa iā mākou ka ʻae mai ka FDA e hoʻomaka.
