Biotech Values

[jq1234]

what was SPPI's market cap when Fusilev was approved?

Fusilev was initially indicated after high-dose methotrexate therapy in patients with osteosarcoma, and to diminish the toxicity and counteract the effects of impaired methotrexate elimination or inadvertent overdose of folic acid antagonists.

From Label:

The safety and efficacy of Fusilev rescue following high-dose methotrexate were evaluated in 16 patients age 6-21 who received 58 courses of therapy for osteogenic sarcoma. The efficacy of Fusilev rescue following high-dose methotrexate was based on the adverse reaction profile.

So I am not sure it counted as phase 3 oncology trial. The trials for combination with 5-FU in Colorectal Cancer were run by outside group, SPPI just used their data for sNDA.