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

To: erickerickson who wrote (48055)	12/11/2018 11:30:52 AM
From: sysiphus	Read Replies (1) \| Respond to of 63284

Ooops; see next message. Can't figure out how to delete a message.

To: erickerickson who wrote (48055)	12/11/2018 11:32:18 AM
From: sysiphus	Respond to of 63284

Only $119.00 fdazilla.com

To: erickerickson who wrote (48055)	12/11/2018 12:17:26 PM
From: duwhee	1 Recommendation Recommended By erippetoe Respond to of 63284

Best inspection I ever had was when the inspector spent the whole time playing with my puppy. Worst was when I had five punch list of items to get signed off and the clients dog came out of nowhere, bit the inspector in the leg and drew blood. He left me with a list of an additional 13 petty items ranging from reflective numerals at the curb for the Fire Dept. to verification of rabies shots on the dog. I went up the ladder and asked his boss to intervene or send me a new (non- chew toy) inspector. Boss said no and so the inspector and I both handled it professionally, I completed the list expeditiously, locked up the dog and we left on friendly terms. He handles the area that has a lot of money, where I do most my work so I see him all the time. I still open up with "how's the leg?" and I can tell my clients that no matter how bad they think an inspection could go, at least he's wasn't bleeding when he left...

To: erickerickson who wrote (48055)	12/11/2018 12:20:07 PM
From: rodneyh07	Respond to of 63284

I just know my friend said we will see more in our phase 3 study. Not uncommon to occur...

To: erickerickson who wrote (48055)	12/11/2018 8:50:25 PM
From: ladyPI	Respond to of 63284

from 10/1/16-9/30/17 115 483's issued (Biologics) and 694 (drugs. From 10/1/5-9/30/16, there were 84 493's (biologics) and 691 (drugs)

To: erickerickson who wrote (48055)	12/11/2018 9:13:06 PM
From: ladyPI	2 Recommendations Recommended By bobbseytwins2001 CelebrityEquity Read Replies (1) \| Respond to of 63284

I will add to my response about 483's - FDA has a site called ORA FOIA Reading Room. At FDA discretion, they proactively post 483's and responses and also post the ones that were requested under the Freedom of Info Act. The last post is dated 12/6/18. In 2018, there were 1,254 483's. I did search by company name and nothing comes up for immu, either as a 483 that FDA posted or that was requested per FOIA. You can also search for any written responses to 483's and nothing for immu. Of course, that begs the question, where did FDA News (or whatever that company was called that posted it) get it from???? Looks like an inside job.