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

To: duwhee who wrote (48028)	12/10/2018 6:45:41 PM
From: allatwwk	1 Recommendation Recommended By Smoke Reader Read Replies (1) \| Respond to of 63285

We've known for some time the risks in AA are in the more opaque area of the business, not the data around efficacy/safety. Not that this is linked, but on Aug 13, IMMU was $21.00 per share. By Aug 27, it got close to $27 and dropped back in a hurry. I'd guess it'd take a week or two for the inspection feedback to come back, well before any formal letter. I wonder if the results of this inspection, as they became known, somehow got into the market with the sense the AA filing (or timelines) might be at risk. 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. I'd expect IMMU, with so much riding on this, is moving heaven and earth to get the issues resolved.

To: duwhee who wrote (48028)	12/10/2018 8:40:15 PM
From: EMU2	2 Recommendations Recommended By bobbseytwins2001 JJINV Read Replies (1) \| Respond to of 63285

Or as the contractor who built my house told me. Inspectors aren't paid to just inspect, they MUST find something wrong when they inspect or they're being paid for doing nothing.So the best thing for me to do is purposely make a small easy to find something that is against code. OR the inspector could look and look to find something that isn't there that will cost a great deal more to fix. How many applications to the FDA are 100% correct? The FDA MUST find something that's not quite right in the 80,000 page submittal or the bureaucracy can't be justified.