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Biotech / Medical : Immunomedics (IMMU) - moderated
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To: ghettogoulash who wrote (49646)1/23/2019 1:56:45 PM
From: MFG ENG2 Recommendations

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dorightbythem
Olecranon

   of 63277
 
<I'm not sure why you are still talking about the 483 when Morgan Stanley just said*, even as they simultaneously downgraded us a notch: "Mgt. indicated these issues are NOT related to the prior issues raised in the FDA 483 letter from the summer." >

I just wanted to finish what I started but I also thought there may be SOME value left (even though the time for this analysis should've been before the PDFUA and I apologize for my complacency on that) in showing you guys:

1. What Pehl and team was up against prior to their taking over operations at IMMU. This will help bolster confidence in the new management and show you just how far they've come.

2. The rigors of bringing a manufacturing process to commercial standards and what's expected so we can begin to understand why we might have gotten a CRL. There are a LOT of loose ends to tie up because drug manufacturing demands absolute certainty on matters of quality.

I also know from experience that management is not privy to every little detail on the manufacturing floor (because these details take time to uncover and they're too busy running the business) and when they say the issues are NOT related to prior issues, I question how sure they can be unless they did know every detail and they were, in a previous life, validation engineers to understand what those details mean about the health of the quality ecosystem on the floor. The health of the quality system is EXACTLY what the FDA is looking for and if they come back and inspect. Even if the CRL wasn't related to 483 items, there could be NEW quality ecosystem issues the FDA will find in future inspections if IMMU hasn't FULLY changed the culture around that yet (i.e. legacy employees that regard quality like IMMU USED TO) and that could impact their decision to override the letter and give approval. I just wanted you guys to have the knowledge and perspective on how challenging it can be and the attention to detail it requires for a company to be ready for commercial manufacturing, which ultimately gives a measure on where our risks of "not getting approval" are and might still be. That's all.
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