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This post was commissioned on May 30, 2008, and it was categorized as FDA/Regulatory.

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A few days ago, I scratched my head in amusement over GSK / Ligand’s decision to submit and NDA based on non-statistically significant results for their thrombocytopenia drug, Promacta.

Well, the scientific advisory committee (after lambasting the drug on Wednesday) unanimously voted in favor of the drug today.

Sometimes, I’m pretty sure I’ll never understand the regulatory side of this business. As they say in sports, I guess that’s why they play the game.

For a nice visual definition of “volatile,” check out Ligand’s 5 day chart.

 

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Eben is a highly caffeinated business development associate at a small, cash sensitive pharmaceutical company somewhere in Massachusetts. He enjoys cliche-less banter, compartmentalization, non-equilibrium thermodynamics and NPV analysis. Agree or disagree with what he's posted? He encourages comments.

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