Spectrum Pharmaceutecals Inc (SPPI)

[Tartiaboy]

This is what I wanted to say on the Yahoo board:

There were 30 patients in the BTD sub-group. Of these 40% 12/30 were confirmed responders (cORR). 5 of these 12 responders were censored (lost to evaluation for unknown reasons). 7 of the 12 responders were evaluated to provide the DOR of 6.6 months. Of the 7 evaluated responders 6 have a DOR over 6 months.

Of the evaluated confirmed responders 6 out of 7 have a DOR of over 6 months which is fantastic. However, the FDA wanted SPPI to provide evidence of cORR and 6 month+ DOR.

The 40% cORR was solid, BUT we believe that there were too few confirmed responders in the DOR analysis (just 7 patients) to satisfy the FDA.

Let me know if you agree with this. TIA