FDA/Regulatory

FDA Likes Promacta

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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