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Posted On: 04/09/2019 2:10:32 PM
Post# of 30055
I remember tons of data and discussion about marketing back when Lympro 1.0 was still being developed directly by ambs ages ago. The current release makes it seem like we will have enough data to start moving forward even in 2019. (!)
What I'm not clear on is how hard is regulatory approval for diagnostics? I believe the original plan was to start only with phrama trials, which would mean faster approval, and it seems that is the current plan as well. I read up on it a bit but the FDA documentation is massive and complex, so I'm wondering if anyone else knows how easy it would be to get this moving, with 2.0?
What I'm not clear on is how hard is regulatory approval for diagnostics? I believe the original plan was to start only with phrama trials, which would mean faster approval, and it seems that is the current plan as well. I read up on it a bit but the FDA documentation is massive and complex, so I'm wondering if anyone else knows how easy it would be to get this moving, with 2.0?
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