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.

Theoretically Related Posts
- May 28, 2008 -- GSK submits non-statistically significant NDA for Promacta (1)
- April 28, 2008 -- Elixir Hoping to Cash In On Sirtuins Too After GSK / Sirtris Deal (0)
- February 6, 2009 -- Idenix Take $34M Upfront From GSK For IDX899 (0)
- November 14, 2008 -- BBM Offers to Acquire YM BioSciences for $29M (0)
- October 30, 2008 -- GlaxoSmithKline to acquires Genelabs Technologies for $57M (0)
- October 23, 2008 -- GlaxoSmithKline and AFFiRiS Ink Alzheimer’s Disease Vaccine Deal (0)
- September 10, 2008 -- GSK and Cellzome Announce Alliance over Kinase Technology (0)
- August 8, 2008 -- FDA on Pace to Approve Only 18 NMEs (0)
- July 31, 2008 -- BMS Offers to Buy The Rest of ImClone (0)
- July 25, 2008 -- AutoGenomics Files for IPO (0)
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