Biotech Values

[mcbio]

In terms of taking advantage of the pathway, I would hope once the pathway is fully up and running that would be a less-than-12-month process. But I don't expect it to be that way out of the blocks. This is brand new for the FDA; they're just staffing it up. It's going to be slower, so I'm kind of thinking it will be more in that 18- to 24-month range.

So, potentially two years once the pathway is fully up and running, which begs the question of when, exactly, will the pathway be up and running? Is it going to be another year, to which we assume potentially three years before MNTA/BAX are ready to bring an interchangeable biologic to the market if major Phase 3 trials aren't required?