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exwannabe

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exwannabe

Re: johnn123 post# 117100

Sunday, 03/27/2011 7:26:42 PM

Sunday, March 27, 2011 7:26:42 PM

Post# of 253274

SPPI...Re-Fusilev...The FDA requested additional data which the company expects to submit in the 3rd quarter of 2010. The FDA DID NOT REQUEST any additional efficacy studies.



Per CTIC: http://investor.spectrumpharm.com/releasedetail.cfm?ReleaseID=414919

"The FDA stated in the Complete Response letter that the submission did not demonstrate that FUSILEV is non-inferior to leucovorin; and recommended that the Company meet with them to discuss options for continuing to seek approval of FUSILEV in advanced metastatic colorectal cancer. "

In case you miss the point, NI to leucovorin is the efficacy proof. I never said that another study was needed, just that this is a real issue.

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