Replies to post #151340 on 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?

[iwfal]

MNTA

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.

if I had to pick the most disturbing quote from MNTA management in the last year or so that would be it. Even the simpler Copaxone and Lovenox generics took MUCH more time than a normal generic approval. My personal vote for second most disturbing quote was about their chances on appeal of Copaxone decisions (where they lost on multiple fronts and so to be able to turn it around they would have to reverse multiple largely independent rulings).