Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Will Rolontis be superior to Neulasta?

As a secondary endpoint, it’s not critical for BLA approval but is important in getting a marketing edge to any biosimilars, or to Neulasta for that matter, as a biobetter. So what is the probability that it will meet SS? While I don’t claim to know if it will, I think it has a much better than a puncher’s chance to hit it. Why? Well, we know from the Phase 2 trial that the high dose did meet superiority with a p-value of 0.023 whereas the mid-dose did not (p-value of 0.528). The current dosing in the P3 trial is at 90% of the P2 high dose so you would think that would do the trick. The one thing that bothers me in believing in this scenario is that the secondary endpoint wasn’t mentioned when top-line data came out. That would have been nice to know. So either it didn’t hit its p-value or maybe this is JTs little secret when asked by an analyst several CCs ago on what makes you so confident that Rolontis will be successful. Hopefully, we get to see full trial data at ASCO and not have to wait till SABCS in the fall.