Dec. 4 at 9:25 PM
$IBRX FDA should change its sNDA policy for approved drugs. An FDA approved drug should not be asked to run phase2/3 trials for label expansion. For example, anktiva which is approved for bladder cancer, should not have to run a brain tumor trial for approval. Instead, the real-world evidence should be considered for label expansion. If ~10-20 GBM patients show tumor shrinkage in a single arm open label study, that data is more than good enough for label expansion to GBM. FDA must use some common sense and dump the unnecessary approval protocols.
