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jq1234

04/02/12 9:40 PM

#139649 RE: bladerunner1717 #139647

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.
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biomaven0

04/02/12 9:44 PM

#139650 RE: bladerunner1717 #139647

SPPI's market cap when Fusilev was approved



But then Fusilev was not a typical high-risk new oncology drug. Already approved and widely used in Europe and a known and well-understood variant of an approved and widely used drug here in the US.

In some sense this AF rule is just the efficient market hypothesis in another guise. Any really promising oncology drug in Phase III is going to be associated with a decent market cap. If the market cap is low, then that implies the market doesn't believe the trial will succeed or (for a drug like Fusilev) that there isn't much market.

Peter