Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

I think your concerns are unwarranted like they were for the Pozi interim data needing KM curves.

How far did Hanmi go with clinical trials? (my understanding is not far past phase 1). Were the clinical trials of acceptable quality to meet FDA standards? (i.e. even if they bridge, will the FDA accept the data?) -stugwins.

I'm sure all the Hamni pre-clinical and phase 1 trial data was accepted in the IND. If the IND wasn't accepted do you think Spectrum would have been able to run a Phase 2 trial as well as 2 phase 3 trials? And besides, they did run a Phase 1 trial in the US as noted

http://investor.sppirx.com/releasedetail.cfm?releaseid=754834

Spectrum Pharmaceuticals Initiates Phase 2 Study of Long-Acting GCSF Drug Candidate, SPI-2012, for the Treatment of Chemotherapy-Induced Neutropenia
• In U.S.-based Phase 1 trial, SPI-2012 demonstrated increase of neutrophil count similar to Neulasta® (pegfilgrastim) at one-third the dose.

Regarding

How about CMC? (i.e. analytical methods, process, scale-up etc?. I assume you know that in Biologics this is much much more important than in small molecules) -stugwins

I don't share your degree of concern here. Sure, one must be wary after Apotex, Sandoz, Coherus and Mylan all had there applications delayed (although Mylan's delay was not for the drug but for the plant where it would be manufactured getting major 483s) but by the same token, Spectrum/Hanmi have a road map on the Do's and Don'ts with regards to submitting their application. Coherus' CCs after their CRL were enlightening.