Replies to post #1932 on Spectrum Pharmaceutecals Inc (SPPI)

[Ville]

351-a pathway. It is a new drug, no biosimilar!

[antihama]

Correct, I was looking at my notes from Analysts Day on SPI-2012 which was right before the discussion on Evomela where Dr. Hari mentioned 505b2 and I didn’t realize it was Dr. Hari talking about Evomela.

Regarding

So what is the regulatory strategy on Rolontis? 351a or 351k?

I would have to say 351a. Why? Well, besides that at almost every CC they indicate that Rolontis is a novel molecule, another sign is they are measuring Duration of severe neutropenia (DSN) which is an endpoint for efficacy. If they were taking the 351k route they would be measuring potency rather than efficacy.