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Biotech / Medical : Immunomedics (IMMU) - moderated
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To: JohnBeach who wrote (49647)1/23/2019 2:03:36 PM
From: MFG ENG  Read Replies (1) of 63283
 
<MFG ENG. Your input would have been helpful a month ago. I know I'm late to the party, sorry. Now, you are just pounding a drum. Everyone knows now that the CRL issues don't involve the items in the 483. I mentioned in a previous post today that knowing the 483 items and what they mean informs us of the health of the quality system at IMMU, which is what the FDA looks at. They were PRETTY sick before PEHL came in and it takes time to get well, a lot of times more than a year. Hopefully they've turned the corner but there's still value in knowing what we're up against in terms of overcoming that sickness so we can be healthy enough to receive approval from the FDA. You didn't have time to write a single post in 2 years, but now you found the time, post CRL, to write 8 very long posts in 3 days. I've been complacent with my investment. Now that I've lost money for my friends and family, it's been a wake-up call and I was motivated to do at least something. Also, up until now, we've not had any information that I felt qualified to comment on. Last night you took the time to write 3,088 word post on the subject.

Why?>

To finish what I started and to hopefully leave you guys with a more informed picture on how far IMMU has come under current management's leadership and how far it might still have to go. It's mainly there for interested parties to have a read and to reflect upon.
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