Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Can successful Poziotinib US P2 trial results for metastatic breast cancer receive AA? At first I didn’t think so but now I see a possibility. I didn’t realize that the US P2 Poziotinib study had ORR as the primary endpoint. Prior to Yahoo going stupid with their new format which coincided w me not posting there anymore, I lamented about the US poziotinib P2 single arm metastatic BC study not being able to be considered for AA approval. The reason was I thought that the primary endpoint was PFS and that is not enough to be considered for AA (I mentioned it in the previous lonked post also). So I was just checking CT and I see the primary endpoint is ORR which is good enough of an endpoint to be considered for AA! I must have been looking at the similar Korean poziotinib P2 single arm metastatic breast cancer study which had PFS as the primary endpoint (which Raj was claiming back in the spring would be considered for Korean approval???not sure about that).