Ok, I have said in the past that I think Pixantrone has a 50/50 chance of approval, today I will outline where I derive that estimate from by breaking it down for the readers. In reality the drug should probably be approved because of the lack of treatments out there for the relapsed group, but it doesn’t work that way. The FDA has to give the go ahead and getting approval from them is easier said than done. So here we go.

The 50% For Approval:

10% for the strong response data, 40.0% of patients had a response compared to 14.3% on the comparator arm

15% for the Complete Response data being strong, Overall Response Rates consist of Partial plus complete responses, and Complete responses mean the disappearance of all signs of cancer in response to treatment. So anytime you have slam dunk numbers like this it bodes well for approval.

15% for the Progression Free Survival data being strong, at 5.6 months vs 2.6 months, you high statistical significance that Pixantrone is working. Progression free survival is the length of time during and after treatment in which a patient is living with a disease that does not get worse.

10% for the Median Overall Survival data with patients taking Pixantrone living an average of 10.2 months compared to 6.9 months for the comparator arm.

cont’d on next page

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