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Biotech / Medical : Adolor(ADLR)Maybe the Answer to the Pain of Owning Biotechs!
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To: keokalani'nui who wrote (8)11/10/2006 12:19:18 PM
From: keokalani'nui  Read Replies (1) of 21
 
RE42, you should listen to the call if you haven't already. It is only available via phone replay and only for a couple more days.

So to answer my own dumb question, sometimes I think I'm getting stupider by the hour, the amended submission satisfied the efficacy issue merely as a paperwork constituting a complete response. FDA statisticians will surely rip apart the data. I hope adlr/gsk submitted their conclusions about efficacy under only the most conservative assumptions.

The call left me worried. "Combined results from all completed studies in the chronic population submitted by GSK to the FDA did not support a conclusion that patients taking alvimopan were at increased risk for serious cardiovascular events." At first this was reassuring, but it was chanted a few times too many. And in the face of some direct questions about specific trials, specific doses and regimens, a direct answer about the presence of a CV issue in a particular trial would have been appropriate but was avoided and answered with the chant. What went unsaid spoke loudest.

And the final question made clear to me that the FDA by asking for a risk management plan shows it is much more concerned about the CV profile today than simply waiting for the finals results of x014 study to fatten the database. That is, if x014 ends up totally clean there still will be a RMP!?!

Worth pointing out the nice cash cushion, BTW. Hope you make a killing. I can't quite decide what is up with it.

(End of ramble.)
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