| | | Message #49563 from weatherproof at 1/22/2019 6:51:26 AM
Finding #1
Hi. I'm your friend. I'm only 31. I got hurt by IMMU just like the rest of you. I'll try to dissect things for you in my objective, humble, been-away-from-this-for-a-longtime, sort of way. Be gentle. Haha. (i.e. First time poster ingratiating itself with the board)
I am in fact gratitude to you guys. I felt like I had nothing of value to contribute prior to the 483 because you guys had covered everything from idaho's initial calls with Bezhad (in 'zhad we trust) to the ORR rates that I would never go and try to read for myself if not for you guys showing me the value over your many informative posts. Still ingratiating here but you all are like celebrities to me, I've been reading your comments for over 2 years and they're largely responsible for me taking up the "all-in" position I have with IMMU.
Finding #2
You can stop me anytime (if you happened to be awake between the hours of 10:00 PM and 4:00 AM on the night/morning before the market opens after a 3-day weekend and a terrible event in the form of a CRL a couple days before.)
Sorry, it hadn't dawned on me...the optics of the timing of my posts. In fact, I live on the west coast and started the 1st two findings at work, left to have a workout, then came home and started working on the next few posts at 11pm my time or so. Hence, I finished around 1:30am and was probably a little cranky so I just let my thoughts out. Of course, they might be colored by the massive loss I suffered over the weekend...Again, I apologize if it came across as "short raiding".
Finding #3
Let's not consider that maybe IMMU was working to remediate these issues in February 2018, or even long before that. Let's forget that IMMU was aware of the issues long before August 2018 and just pretend they only started addressing the issues post inspection, or post-483.
If they were aware of these issues long before August and were working on remediating them, fantastic. I hope nothing more for a speedy turnaround for approval in spite of my analysis, which I'll admit, has on occasion turned out to be wrong. IMMU could have addressed all these things already but given that they still got this 483 in August with all the specific findings means they haven't fully addressed them yet to the FDA's satisfaction. It's because it's that late in the game that we're getting these very specific and fundamental quality system stuff findings that I started getting very discouraged with their manufacturing team.
Finding #4
And here it comes in boldface, no less:
"I’m saddened and sorry that I didn’t have the chance to get to this before the 17th so I could tell you all that there’s no way in hell I’d approve a company that runs like this."
"I’ve failed you guys because had I read and started dissecting this earlier while noting the dates of inspection, I’d have sold and waited to see what happened because the future definitely became uncertain based on this 483. "
With all your knowledge and given your stake in IMMU, you'd have us believe that you're only now giving the 483 a serious look. The thing is, I could have handled it, even appreciated it if you laid out the 483 and interpreted it for lay people, however bad it looked. As I said, if it turns out that IMMU f'd up, shame on them. It's all of the other bs with an agenda that I can't handle, and I can't believe people fall for it! You have no clue, and nor does anyone else at this point, how far along IMMU was in remediating issues that they started addressing long before August 2018. We don't have all the facts, and pretending that you do at this late hour before market open smells like crap to me.
I am but a retail investor who didn't really know how to seriously invest before you guys. I know with your years of experience and success it's hard to believe but people have to start from scratch and that's me. Mix that in with a very busy holiday season at work and in life (preparing for a long holiday stay in my hometown, buying gifts and stuff) and I just kind of went into autopilot since a few on the board had said that these issues were being fixed. I am embarrassed to admit that I had my entire portfolio in this thing and just breezed over the 483. I'm an idiot.
I will admit I have no clue like everyone else. This is merely reading the tea leaves with what I've got, the 483. The late hour before market open is coincidence and a poor decision on my part if it's what's causing your suspicion. I just want to give back to the board that's given me so much over the years and I saw you guys grasping for a reason why things happened the way they did. The only thing I thought was, "maybe I should actually look at this 483" and after heavily scrutinizing (unlike the type of reading I'd do at work with people breathing over my neck) the document, I was a little dismayed to see the kinds of things I did that late in the approval process. With that, it's off to work. I will be monitoring and trying to further explain myself as I can today. |
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