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Re: 1st Comm Squadron post# 3033

Friday, 11/20/2009 9:23:05 AM

Friday, November 20, 2009 9:23:05 AM

Post# of 7234
Hi 1st Comm Squadron, I went to the CTIC website and found the following quote:

"The U.S. Food and Drug Administration (FDA) accepted for standard review our New Drug Application (NDA) with a Prescription Drug User Fee Act (PDUFA) action date of April 23, 2010.

Pixantrone has fast track status and its proposed indication is for the single-agent treatment of patients with relapsed or refractory aggressive NHL who have received two or more prior lines of therapy."

Great to see it's been fast-tracked. Can you tell me what the term "action date" means? Does that mean they have approval and can begin marketing Pixantrone after that date? Or, do they still have to do more clinical trials and therefore more waiting. The idea of a sale to Novartis is very exciting. Any further info on that?

Thanks.

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