Replies to post #129955 on Biotech Values

[biomaven0]

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.

http://www.siliconinvestor.com/readmsg.aspx?msgid=27433549

and a few post later

... 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.

Peter