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Re: meirluc post# 212301

Sunday, 02/03/2019 1:22:54 PM

Sunday, February 03, 2019 1:22:54 PM

Post# of 689403
I believe they’ve indicated it’ll take a couple (2-3) to several (3-4) months, not years. Does that include the submission and approval of it? Probably. Ex has implied it would take around 30 days after submission for the FDA to respond, and my bet is, the FDA and other RAs know it’s coming. Maybe it will take longer. I don’t know. But it sounds like they have the kind of heavyweight help they need to help assure the FDA and the others they know what they are doing.

And I’m not sure how much more clearly they can state they are moving quickly on all these steps then that they are putting the pedal to the metal to do it.
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