After reading the material with some care, that, for the very little that it is worth, is my prediction, too: Approval and a demand for some further post-approval testing.
The concerns seem to boil down to: uncertain mode of action; consistency of manufacturing; why did the earlier trials fail/what has changed; and is 45% supportable as a figure for the null hypothesis in the single-arm trial now relied on? There look, to my admittedly inexpert eye, to be good answers to these questions.
Ans although the failure of the earlier trials to reach their primary end-points seems to loom large, if it was going to be decisive, we wouldn’t be here.
After reading the material with some care, that, for the very...
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