AGVHD 100 day survival., page-4

100 day survival is a secondary endpoint

For those unfamiliar with how the FDA approval process works, the only requirement needing to be met before approval is given is the primary endpoint.

It works both ways, so if you fail your primary endpoint and meet all secondary endpoints, it still means your trial failed.

That is not to say that being able to meet secondary endpoints is useless, rather it can be used in various points in your NDA, potentially impacting your marketing and labeling.

But it shouldn't in itself, lead to the FDA rejecting your product registration.

the 28 day outcome was the primary endpoint and the 100 day test in the primary endpoint is for safety only i.e. testing for severe adverse events, toxicity etc

Have a read of the trial details in the below link:

aGVHD clinical trial