Following a Type D meeting with the United States Food and Drug Administration (FDA), Amplia Therapeutics has received feedback on proposed modifications to our US clinical trial protocol for narmafotinib, our best-in-class FAK inhibitor. The trial will study narmafotinib in combination with FOLFIRINOX chemotherapy for advanced pancreatic cancer patients.
A Type D meeting is an opportunity for a company to seek feedback from the FDA for specific questions regarding clinical development activities.
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.
Amplia CEO and MD Dr Chris Burns commented:
“We are grateful for the thoughtful input from the FDA regarding the modifications to our clinical trial protocol. 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.”
Click to read the ASX Release.
