Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

I think we just dodged a bullet.

I believe that's more accurate now than when I wrote it initially. Listening to the Merrill Lynch CC, Raj mentioned we won't have Rolontis top-line data till about a year from now (he also mentioned it at Deutche Bank too but I missed it till I went over it again tonight) So hearing it today, I said to myself "What?" At the last quarterly, Raj said

As of today, approximately 75% of patients have been enrolled in this study. We expect to complete enrollment by the second half of this year...Since January of this year and as of April 30, enrollment over 135 patients in this pivotal trial.

At this rate it would take about 3 months to recruit the last 100 pts. That takes us to August and results generated a short time later so why does it take a year from now to get top-line data? IMHO, it's because they need this PK study to finalize and submit as part of the BLA application. A much weaker argument would be that they need to get the 2nd P3 trial underway to show the FDA, something akin to a confirmatory trial in AA but as I said that's a much weaker argument. So while this new PK study will enable them to avoid a CRL, it seems to have delayed submission of the BLA. I admit I have limited knowledge of what's going on but I have no other way to explain why the study results are being delayed till next year when recruitment should be ended in ~August.