Ann: Type D Meeting Outcome With US Food And Drug Administration, page-2

"The Company sought the FDA’s feedback regarding modifications to the clinical trial protocol previously submitted as part of the Investigational New Drug application cleared by the FDA in January 20242 . Specifically, the Company was seeking commentary regarding changes to the dose-escalation and dose-optimization phase of the study and concerning removal of a pharmacokinetic assessment of FOLFIRINOX in the trial. In the written response received by the Company, the FDA noted that the proposed changes ‘appear reasonable’ clearing the way for the Company to finalise the study protocol and initiate the final stages of trial planning prior to commencing the study".

Looks like the updated data and trial outline has been well received by the FDA, approving these changes prior to the trial starting; seems like everything is going steady steady..

Additionally Dr Burns noted "these changes will allow the Company to progress the trial in a more time-efficient and capital-efficient manner, and we are now in the final planning stages to start the trial in the coming months".