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<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.
Since the rules of this board are to act like an adult and Idaho requested to cut down on the number of posts, I will refrain from pointing out the many issues in your post to me and I didn't find much value in reading your 3 quick posts. Make that 4, you slipped another one in while I was writing this.
Let me just provide a lesson in logic.
If I were to post the following:
In my opinion: 1. Lee Harvey Oswald was the lone shooter. or 2. There were shooters on the grassy knoll. (but possible the shot came from another location, but don't think so).
Would it then be accurate to deduce that I believe there were shooters on the grassy knoll? Answer is no. I'll let you work on that and if you can't figure out why the answer is no, you can let me know and I'll explain.
<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 towrite 3,088 word post on the subject.
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.
"My comments: The FDA is kind of beating a dead horse here. We know IMMU was not great at preventing contamination"
I am not convinced anybody knows that. All conjecture at this point.. we have very little facts. The crucial word in my comment is "was". I KNOW IMMU was not great at preventing contamination as fact because the 483 told me so in clear words in at least 2 of their findings. You just have to be able to interpret the complaints the FDA had which I can because this is my life as a biomedical device manufacturing engineer. My hope is that Pehl and crew have turned this around and uncontrolled contamination will no longer be a specter in subsequent inspections by the FDA.
Would really like to see the actually CRL, and a complete response by IMMU magmt. Me too because then I would know the scope of what remediations they are still on the hook for and can better guess at a completion time for that. Is there any way to request this information through the Freedom of Information Act?
<Nice try...actually better than most we see here. But here’s some advice for your approach to your next target. You need to decide if you are going to present yourself as sophisticated, well informed and intelligent OR as innocent, naive and helpful. There were many thoughts going through my head as I went over the findings. The more you read and dissect the more your opinion changes...sometimes it's in one direction, other times it's in others. Some subjects in the findings, I'm well-informed on...others, I have to cover my @$$ on a little because I'm not 100% certain of what the implications are. That's probably why you sensed both tones. One or the other. Here, you couldn’t seem to settle on how you wanted to be perceived and it unmasked you. But, hey, when compared to others we have seen come on this board you were, as I say, better than most. Any hints where you go next? I'll be right here. This board has given me a lot of hope and courage to stay in this stock as long as I have. You guys are knowledgeable and entertaining. I hope to be here when we can all celebrate "silly" PPS's. Just curious.>