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

To: weatherproof who wrote (49555)	1/22/2019 8:20:24 AM
From: bnutman	4 Recommendations Recommended By bobbseytwins2001 diaperdaddy patlawche11 rodneyh07 Respond to of 63318

>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.< The timing and new poster (added Jan 21) smells rotten to me also.

To: weatherproof who wrote (49555)	1/22/2019 8:34:37 AM
From: zevenhuizen	5 Recommendations Recommended By bobbseytwins2001 diaperdaddy ladyPI patlawche11 Vanderm_98 Respond to of 63318

I'm with you weather. I just cannot imagine our management team and board with all that experience would screw up all those listed items that bad. If that would be the case you could compare their management with the previous management whose names cannot be spoken here and I just cannot get there.Not with all these credentials. But time again will tell. For now I stay with the science and management and let the other issues play out.

To: weatherproof who wrote (49555)	1/22/2019 8:40:45 AM
From: ghettogoulash	4 Recommendations Recommended By bobbseytwins2001 diaperdaddy patlawche11 rodneyh07 Respond to of 63318

I was thinking the same thing, weather. That is quite a doomsday analysis by our new friend. We've concluded that these 483s are routine and expected in BLA submissions, and in this case, not even deemed material for disclosure. And let's not forget that thousands of patients have been infused with IMMU's therapeutics in the past twenty years without incident.

To: weatherproof who wrote (49555)	1/22/2019 9:20:50 AM
From: sogwap1	1 Recommendation Recommended By Renmanco Read Replies (1) \| Respond to of 63318

Hey, another Favus report, however much more thoughtful and convincing. Their other attacks were just body blows, this one is a direct head shot.

To: weatherproof who wrote (49555)	1/22/2019 9:55:12 AM
From: sogwap1	2 Recommendations Recommended By bnutman rodneyh07 Read Replies (1) \| Respond to of 63318

I filed a TOU on our new "expert". Don't be surprised if these posts show up on other websites, blogs and articles soon.

To: weatherproof who wrote (49555)

1/22/2019 11:34:54 AM

From: MFG ENG

1 Recommendation

Recommended By
Planeteer

Read Replies (1) | Respond to of 63318

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.

To: weatherproof who wrote (49555)	1/22/2019 12:38:29 PM
From: idahoranch1	9 Recommendations Recommended By bobbseytwins2001 btlbail1 dorightbythem EMU2 erickerickson and 4 more members Read Replies (1) \| Respond to of 63318

I’m with you weather with the suspicion of the motive of those posts, but I did like learning things about the process as that’s what needs to be fixed. The one thing about being in Maui is that the time difference is great enough from most of the mainland that I was reading several of his posts when the evening was still young and it didn’t occur to me that he was up all hours of the night before the first day of trading, that would have been a bit of a flag to me. There were 3 or 4 sentences that did lead me to think “motive” which we aren’t supposed to judge here, so I won’t. One was “Then I remembered I was long”. I recommended some of the posts as I felt the information was valuable, I want to know some of those things. I don’t believe, maybe naively, that the issues brought up are as bad collectively as I believe most have been remedied and as a couple of posters have mentioned, if they were as bad as presented, how could they still be treating patients in the trials? There’s been no halt by FDA of any clinical trials, if there were it would have to be made public. So here we are in the $12’s, almost perfectly where the Goldman Sach’s report said we would be if we got a CRL. We are holding up OK given the market and sector weakness today. We got a report from our drive by guy that there were 40 cars at the company on a holiday yesterday, I’d guess a few were for manufacturing and most were digging into what the heck happened.