Spectrum Pharmaceutecals Inc (SPPI)

[Tartiaboy]

" The company plans to discuss the results with the U.S. Food and Drug Administration (FDA) regarding a potential new drug application (NDA) filing for accelerated approval. Umbralisib was recently granted Breakthrough Therapy Designation (BTD) by the FDA for the treatment of adult patients with MZL who have received at least one prior anti-CD20 regimen."

So it looks like they are not concerned about upsetting the FDA.

Maybe SPPI is just much more conservative or maybe SPPI doesn't want to share that data before getting a PDUFA decision for Rolontis. Just suspicious.

Don't know if you are interested but I am really excited about a new company called Replimune. Very exciting!