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.
The whole rest of the article made sense and put pieces together - but this is bizarrely optimistic. Lovenox and Copaxone took 6 years or so - 4 years longer than typical. Why would anyone assume that this will take less extra time here - when the problem is just as politically risky for the FDA and scientifically of the same order of complexity?
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