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

To: allatwwk who wrote (48030)	12/10/2018 7:57:24 PM
From: weatherproof	6 Recommendations Recommended By drtom1234 erippetoe idahoranch1 LLTD patlawche11 and 1 more member Respond to of 63285

>>The list of issues strikes me as correctable -- with potential for a delay in AA as opposed to a denial, but devil is often in the details here, so consider me nervous.<< Knowing that it is not a warning letter, but rather an acknowledgement of certain correctable deficiencies that IMMU was told about, vis-a-vis that Form 483, in August, AND, hearing Pehl state that they'd be ready launch in a matter of days from AA, I'm not that nervous. I'm sure IMMU talked through the issues on that 483 with the FDA back in August. They didn't just learn about this on Friday, the day this abortion of a headline (since changed) came out. As an aside, I read that the issues on the 483 are listed in declining order of importance. So #1 was the biggest concern. I have to imagine that IMMU responded within the alotted 15 day period from that August date and since then have reviewed protocols, and such with the FDA and to the FDA's satisfaction. Anything less than that would be material and I think we would have heard about it. All my opinions.