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Biotech / Medical : Immunomedics (IMMU) - moderated -- Ignore unavailable to you. Want to Upgrade?

To: weatherproof who wrote (49397)	1/20/2019 1:56:33 PM
From: rkrw	Read Replies (1) \| Respond to of 63329

Sure. Form 483's are routine, 6 observations is actually a pretty clean review. IMMU didn't get the job done. SGEN's Adcertis got approved, first try, no issues, they are competent.

To: weatherproof who wrote (49397)	1/20/2019 5:42:30 PM
From: ladyPI	2 Recommendations Recommended By bnutman JJINV Read Replies (1) \| Respond to of 63329

Getting the 483 was not the end of the world although they had a year and half to scrutinize manufacturing and supposedly top notch people. I wonder why they did not catch anything? Be that as it may, it was a huge wake up call when they got it. Looks like they made assumptions - was there no reinspection ? Or did it take them up to the last minute to fix things? I can only hope that the company sheds more light on where the failures were, what they were, and how will they remedy . Frankly, I don’t want to hear anymore from pehl. Put someone else out there to talk to us. Hire a top notch PR firm, ASAP