IND for ALA-101 accepted by US FDA
Dr Michael Baker, Managing Director and Chief Executive Officer of Arovella Therapeutics, said: “The team has done an amazing job capturing all of the experimental data and related technical information required for a successful IND submission. To have it accepted by the U.S. FDA demonstrates the capability of our team and the Company’s selected partners, including our manufacturer, Cell Therapies Pty Ltd. We have initiated the activities required for our Human Research Ethics Committee (HREC)submission and clinical trial site selection and activation. Now that the IND is accepted, we look forward to accelerating these activities and taking ALA-101 into the first-in-human phase 1 clinical trial. We are hopeful that ALA-101 will bring meaningful benefit to patients enrolled in the study who would otherwise have no remaining treatment options.”
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