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Biotech / Medical : Immunomedics (IMMU) - moderated

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From: dorightbythem	1/23/2019 11:38:23 AM
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More from Ricki Fairley - the only individual poster allowed on Immunomedics twitter feed " Cancer Does'nt Shutdown" - Ricki Fairley? @RickiDOVE 7m7 minutes ago Ricki Fairley Retweeted Scott Gottlieb, M.D. @SGottliebFDA @US_FDA Cancer doesn’t #shutdown @TNBCFoundation Doright - "Serious Issues Ahead. I look at this as our New Gold Card Moment; everyone Poked that Bear." Shutdown risks delaying FDA approval of potentially lifesaving drugs and therapies Published Tue, Jan 22 2019 • 12:30 PM EST \| Updated Tue, Jan 22 2019 • 5:16 PM EST cnbc.com FDA Shutdown Update: CBER/CDER just had a "town hall" meeting. Here are the takeaways: (1) PDUFA will end 2/17 but may stretch to 2/28; (2) Compounding has used all fees and has run out; (3) GDUFA still has months funding; (4) CFSAN – 95 % furloughed; (5) ORA – 70% furloughed FDA chief to staff yesterday, re: what will it take to restart the gov't: "If this shutdown ends because of something that happens on our watch, that will be wrong." Scott Gottlieb, M.D.?Verified account @SGottliebFDA THREAD: We've received multiple inquiries about which critical food operations continue during the shutdown. Examples of the work that we're still doing include: 1) High-risk domestic food surveillance inspections; 2) foodborne illness surveillance and outbreak investigations; 5:19 AM - 22 Jan 2019 Scott Gottlieb, M.D.?Verified account @SGottliebFDA Jan 22 3) Execution of high-risk food recalls; 4) Inspection of foreign food facilities; and 5) Sampling of imported food samples (including sampling for antibiotic residue contamination and decomposition analysis). These are among critical activities ongoing by dedicated, unpaid staff.

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