GSK's Promatica Gets Thumbs Up on NDA

A few days ago, I scratched my head in amusement over (GSK) / Ligand’s (LGND) decision to submit an 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.

Comments

[gillet01:]

Remember that the FDA is staffed with , how can I say this, not the top level, of scientific minds. Clearly the reviewers who accepted the publication of the study results for NEJM thought it OK. That's why there is an independent panel. Any delay in approval is merely a face saving strategy at this point.

2008 Jun 02 03:29 PM