"So the question comes back to do both parties see that same opportunity arising ? "
I'd say FDA granting Orphan Status concreted any decision Amgen / Onyx where weighing up here.
They defied a big wall of naysayers & sceptics that said not a chance in the world they would get granted Accelerated Approval on mid Phase II data for Krypolis... BUT they pulled it off although only for patients that failed at least two of the already approved treatment options.
PAT-SM6 inducing strong and sustained immunological responses based on the 1/2 dosage to patients that had already been resistant to ALL OTHER available treatment options = I'm sure once again they note how they have seen these events before & are looking to see if the same opportunity may exist.
While Accelerated Approval is never any kind of guaranteed outcome obtaining Orphan Status is always the first step.
Just a coincidence that Amgen/Onyx stepped in 5 days after FDA had granted Orphan Designation ? ?
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