Timeline is pushed out, but is the reward still there?
I think so at these prices. They have an approvable drug based on their recent MTC results, and the drug clearly shows activity in a wide range of other tumors.
I'm also not surprised by the failure to reach an SPA. Here's what I said on SI back in June:
I really wonder if the FDA will give them an SPA for a brand new endpoint. Even if they do, negotiations will take forever.
... basically an SPA commits the FDA (at least in theory) before they have seen the data. So an SPA for a novel endpoint is quite a lot to ask for. And an SPA for accelerated approval is even tougher to get.
That said, I still have a modest position, so this drop was unpleasant. I guess I didn't listen to my own skepticism here.