Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Initially stumped by a new SPI-2012 PK study (NCT03135951) that hasn't started recruiting patients yet with results due by Dec 2017. A PK (pharmacokinetic) study is submitted as part of the NDA submission package and usually is one of the 1st clinical studies that is done before more extensive P2 and P3 studies are carried out so why was SPPI doing this study now? Hanmi already did an extensive PK study but it dawned on me that for the P3 they decided on a higher dose than was looked at by Hanmi. So it looks like they'll need this basic study to make sure they dot their I's and cross their T's for a more complete NDA submission package. Luckily, someone noticed that they didn't have this covered (SPPI or from communication w the FDA) and quickly slapped a study together. Can you imagine getting a CRL for lacking basic PK data? You can see a little sloppiness in the description of the study. The Purpose describes looking at serum while the Endpoints discuss looking at plasma. It also doesn't describe what concentrations they will be looking at. I assume it's ANC. I think we just dodged a bullet.