The shortcut is not having to prove that the Rituxan biosimilar has efficacy in NHL in a set of full-fledged phase-3 trials (plural), as would need to be done in a traditional BLA submission, but rather being able to show similar safety and efficacy to Rituxan in a less demanding phase-3 trial (singular).
But even that might be difficult.
If the trial is a NI CHOP-R vs CHOP-sR (to use the board's now standard terminology), the NI margin might be fairly small. I assume it would be based on some fraction of whatever delta there was historically between CHOP-R and CHOP.
So they could well need a fairly hefty N.
Regardless, the story smells fishy. Are they raising money soon?
The only real positive SPPI has going is that Raj has no control over the bladder cancer drug anymore.