FDA Plays

[jrbritt]

Anyone have any clue as to why Spectrum (SPPI) could not show that Fusilev was non-inferior to leucovorin back in 2009. I know the FDA did not require additional studies - and it has been used overseas for years. It would seem like they should have had enough data at the time, and since there have been no more studies, what has changed???

I couldn't find any posts that were more specific about what the FDA said in 2009.

The market for colorectal cancer has huge potential if they could get approved. Tons of cash, very little debt, and other approved drugs...SPPI is in a great position if they could get a thumbs up on this.

-JB