Spectrum Pharmaceutecals Inc (SPPI)

[Tartiaboy]

Nice thorough analyis of the Pozi BTD situation. I agree that SPPI could potentially refile for BTD designation, but not sure of its practical value.

I am more concerned that SPPI has a sober understanding of what the FDA wants to see in an accelerated approval filing based off cohort 1 data.

The last thing we want to hear is that SPPI will not file for BLA based on cohort 1 readout.

I'm confident that the ORR, DoR and DCR will be impressive, but have to take SPPI's word that it is what FDA needs for approval.

On pins and needles waiting for FDA to accept the Rolontis BLA application. Nothing is a given with SPPI.