Traditionally, a pivotal trial can only be against an approved agent. That's a kind of head-in-sand approach when the approved agent isn't in fact the SOC, but that's still the world we live in.
Really there are two issues - one is whether they will get FDA approval, and the second is whether the product will be a commercial success.
I don't follow the company or the space at all, but from my quick reading it seems that FDA approval is likely but that commercial success is still quite unclear.
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