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Re: Biobillionair post# 170076

Friday, 01/04/2019 3:40:11 PM

Friday, January 04, 2019 3:40:11 PM

Post# of 428821
BioB: Yes, the ick factor is certainly there-
duck manure.

I read an article in WAPO yesterday where a consultant was quoted as saying he's afraid of the backlog that FDA will have to push through whenever the shutdown is lifted. A quick search of the consultancies does show past experience, post-shutdowns with CDER-regulated products is to build the new backlog delay into a timeline. Should I assume then by the time AMRN is ready to file in 60ish days? that we can add another 3 weeks and counting to original forecasts for either an expedited or regular approval process due to the shutdown imposed backlog?

Meanwhile Scott Gottlieb is tweeting that he's not leaving the FDA.

My wild guess is that the shutdown is lifted by Sunday night.
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