RE:RE:RE:RE:How does Accelerated Approval work This post appears to be missing : inthno/Da-man - you need to listen to the Q3 CC more carefully, since below is what Thomas Heineman exactly stated - confirming that mBC will seek Accelerated Approval.
" After discussions with key opinion leaders, our biopharma collaborators and the FDA, we have identified an approach that can generate primary endpoint results within two years of the start of patient enrollment accordingly our next planned breast cancer study is anticipated to be a registration enabling large phase two study of around 180 HR positive/HER2 negative metastatic breast cancer patients.
We would use progression free survival as a primary endpoint, and would power the study to achieve a phase three level of success if the expected clinical benefit is achieved as Pela based therapy demonstrates a progression free survival benefit comparable to that seen with [Bracelet-1] we anticipate seeking licensure, potentially through the accelerated approval pathway.
This approach has been used to achieve the initial approvals of other breast cancer treatments, including Pfizer's Ibrance and [Daichii Sanyo's Enhertu]. We believe this is a cost effective and efficient strategy for the development of pellet and breast cancer."