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Re: rajaram46 post# 129955

Tuesday, 11/01/2011 10:38:09 AM

Tuesday, November 01, 2011 10:38:09 AM

Post# of 257644

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

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