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

To: stockdoc77 who wrote (49516)	1/21/2019 8:12:57 PM
From: kdd999	1 Recommendation Recommended By rodneyh07 Respond to of 63287

Good point, Doc. But they should keep the team and bring in the right fda consultants to get this done asap. Problem is, shutdown might be an immovable object. Btw, when they do an inspection, my experience with feds is they tell you specifics on the spot. The immu team that escorted them for a week long inspection has a very good idea what was wrong. They dont just write a cryptic note on the 483. Note that multiple immu personnel signed each page acknowleging the observations. Let' s get real. They know exactly what is wrong. They may not know exactly what it takes to get it right, but that is what the ex fda folks are supposed to tell them. Honestly, everything on there is common sense. You test each level, keep the data fastidiously, keep track of ingredients, clean room data, etc. There is always a possibility that a final test is so complete that some of the earlier stuff can be overridden, but this is what a good system/process engineer can explain. They have to have people who know all this stuff, they couldnt have repeatedly made the product otherwise. Looks like they did not put the right people on the response team. I really think the problem is that those extensive lab mods are still in process, and the fda probably needs to reinspect. If LRDCs observations are correct, they still are not done!

To: stockdoc77 who wrote (49516)	1/21/2019 8:26:22 PM
From: blessedtobehere	Read Replies (1) \| Respond to of 63287

Agreed about the CRL, but what about the 483, what about the communications leading up to the CRL? Shouldn't the FDA, rather than being opaque, be as transparent as possible in their requirements, especially when dealing with cancer treatment? In my opinion, I'm beginning to see 2 groups of people on this board: Group A - I'll call the, isn't the government really nice when they GIVE me a tax break. They are very benevolent and gracious. Group B - The government works for me with the tax money I EARNED and I expect them not to waste it. In regards to FDA vs. IMMU management. Group A - I'm a stockholder and if the FDA says IMMU didn't do enough then I blame management. I essentially hired management with my Gold vs. White vote and I chose to buy and hold the stock. Even though we have evidence that an enormous amount of work was being done onsite in response to the 483, don't blame the FDA because they are beyond contempt, they provide information as they deem fit because they are the FDA. And please, don't anyone get them mad at us. I blame management until proven otherwise. Group B - I am a member. We didn't elect members of the FDA or have input on their hiring, rules of governance, authority, etc. We have no control or visibility into who they are, competence, integrity, etc., even though they are our employees. They work for us at our expense, for overall benefit of U.S. citizens. Yet, as their employers we have no oversight, no visibility into their decisions. With all the evidence presented, with onsite verification of work in progress by a poster on this board, I want and expect detailed answers from the FDA because they work for me. I blame FDA until proven otherwise.