"CMT management held a Type C meeting with the Food and Drug Administration (FDA) on 16 January 2024. FDA provided its written responses regarding potency assay development and comparability studies for Elate Ocular® drug given the pathogen inactivation steps to be implemented in the drug manufacturing process. CMT management is assessing the FDA’s written responses and reviewing the Elate Ocular® development plan. Regeneus believes it to be unlikely that Phase 3 studies can be initiated in 2024, as originally disclosed in the Shareholder Update Presentation on 28 September 2023." (emphasis mine)
I was wondering why a phase 3 trial company would be so cheap. The 100:1 consolidation will push the SP to 70c and give them more leg room for a discounted CR to pay for the trial. Still looks interesting but probably need to wait til Q4 2024 to see how things look.
