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neuroinv

01/24/08 6:43 PM

#15067 RE: enemem #15064

Each to his own analogies...and in fact in yours, Edmund Hillary made the right call in persevering in spite of the 'signs.'

What I don't think is accurate in your premise is that Cortex's consultants could call Laughren and find out if he's going to approve the IND. If he took calls from every consultant and advocate for each drug passing before his Division, he wouldnt have time for much else. Were consultants able to obtain that kind of clarity, Big Pharma programs (who can afford any consultant) would not go down in flames when drugs are declared 'nonapprovable' or 'approvable.' If Cortex's consultants failed, then so did Wyeth's (bifeprunox), GSK's (Gepirone XR), Pfizer's (indiplon)....just to list three examples.

It also presumes that he'd made up his mind in advance, while it's quite possible that until the time he met with the Psychiatry statisticians and reviewers to discuss the case, he wouldn't have made up his mind, because it wasn't on his mind. It's not like Cortex was the only thing on Psychiatry's plate last year. Laughren was never going to look in the 6' box--question is; how much of it did his subordinates look at? Did they understand all of it?

It's likely that he saw the summary, decided that he didnt understand the anomaly, and if he didn't understand the anomaly, he was going to say no--and then had a subordinate make the call. I wouldn't want to scuttle a lead program based on trying to forecast this kind of bureaucratic process.


NeuroInvestment