Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Rolontis' Good Supplier Management Practices.

Some other thoughts while on the subject. Not talking about immediately but almost concurrently and after approval. While it's a gimmie to extend the Stability testing to 36 months (assuming it's stable), there are other things you need to do. Right now Hanmi is probably doing it all i.e. producing Active Pharmaceutical Ingredient/bulk drug, packaging product, and specification testing to release drug. On Spectrum's end, Quality gets the Certificate of Analysis/Certificate of Conformance from Hanmi, reviews them, and releases product for shipment to Spectrum's Distributors. On approval, or perhaps before, you want to get a 2nd, and perhaps a 3rd CMO, lined up to manufacture bulk drug and package/test the product. It depends on how big of a product it becomes. Say Rolontis becomes a $40M product, well probably not worth the time, to get a 2nd CMO (note - when I say CMO, it could actually be many separate entities (API/bulk drug, Packager, and Lab) but if Riolontis becomes a $400M product you'll definitely want a 2nd source to do these things.