But it should have far, far better than that. The only way this could happen is if you are inappropriately giving SIRT to patients with distant mets and NOT operating on patients with liver only disease who have been successfully downstaged by SIRT. If we find out that very few or no patients had surgery then it woud be apparent they had no idea how to use SIRT to its best advantage.
There will be experts there looking at this in disbelief with their head in their hands.
So.
Probably can submit to FDA on the grounds of good safety profile and non-inferority
We now have to wait for SIRveNIB to deliver the goods on OS, but VESPRO may not show it.
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