When Oncology NDAs Fail, Clinical Benefit Is Often In Question
This article was originally published in The Pink Sheet Daily
Pre-submission meetings can address questions of clinically meaningful endpoints and appropriate subgroups, avoiding negative regulatory outcomes, FDA analysis suggests.
You may also be interested in...
Determining the success or failure of a randomized trial requires looking beyond the p-value for the primary endpoint, review articles in The New England Journal of Medicine urge.
In other modifications, FDA tells sponsors seeking Type A meetings – the most urgent category – that data packages must accompany the request.
Two required confirmatory studies will bolster application that relied on historical controls for orphan neurodegenerative disease.