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   Biotech / MedicalImmunomedics (IMMU) - moderated


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From: sukit2/8/2019 9:27:02 PM
9 Recommendations   of 57579
 
Bunch of grown ass men and women getting butt hurt by words on an internet forum. Everyone needs to grow the hell up. The mindless speculation, vilification and conspiracy theory bullshit is growing old and tired. Until the company or FDA gives us something definitive everything else is useless conjecture. What we know...

IMMU was issued a CRL from the FDA
The CRL related to CMC issues
The therapeutic benefits of 132 are significant and not related to the CRL

The company thought the issues were resolved adequate for approval
The FDA disagreed
The company will reapply
The FDA will reassess

We get it...you think Pehl is a lying piece of shit; the FDA is full of people on the take suppressing good medicine; and Behzad is an incompetent VC moron incapable of running a BOD let alone a real company. These point have all been made multiple times and yet we are no closer to the truth nor does any of this discourse give us any real trading or investment guidance.

This month has almost been as bad as the back slapping, high fiving that went on the week before the PDUFA date.


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To: sukit who wrote (50222)2/8/2019 10:14:05 PM
From: weatherproof
11 Recommendations   of 57579
 
Typical BLA review time = 10 months; Priority review = 6 months

Form 483's not uncommon, often followed up by future inspections and additional 483's all performed within the standard 10-month time frame

FDA backlog precludes them from performing post-483 re-inspection within the priority review 6-month time frame

Government shutdown exacerbates timing issues

FDA issues CRL to buy time

FDA will perform re-inspection any day now

What's built into the current price is a Class 2 resubmission with its 6-month review.

If the above scenario plays out, stock goes back to $20's

Next best case, FDA classifies resubmission as Class 1, stock goes to $18

Most likely scenario, Class 2 resubmission = Time for IMMU to fix problems plus 6-month FDA review, stock

hovers around present price of $14

Worst case, weatherproof runs out of present stock of Sambuca Romana and has to call it a night

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To: blessedtobehere who wrote (50214)2/8/2019 10:23:57 PM
From: rodneyh07
   of 57579
 
That Is true...

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To: blessedtobehere who wrote (50218)2/8/2019 10:27:25 PM
From: rodneyh07
   of 57579
 
Agree I was banned and the person that I supposedly said bad things attacked my character and I did not...

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To: idahoranch1 who wrote (50210)2/8/2019 10:30:58 PM
From: ladyPI
   of 57579
 
have a witness to the nasty post before admin, I assume, took it down.

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To: allatwwk who wrote (50221)2/8/2019 11:01:14 PM
From: stockdoc77
3 Recommendations   of 57579
 
A little birdie found and sent it along to me. I'll email it to Idaho and the Ronin and some others in the circle of trust. Ask one of them for it if you are interested. It is from Jefferies and also includes some useful benchmark data on timing of FDA actions. The analysis covers 2013 to 2018 drugs with BTD for oncology and hematology.

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To: stockdoc77 who wrote (50227)2/8/2019 11:14:35 PM
From: ladyPI
   of 57579
 
The FDA Is Basically Approving Everything. Here's The Data To Prove It. Thats the title to google. Forbes

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To: blessedtobehere who wrote (50218)2/8/2019 11:26:26 PM
From: JJINV
2 Recommendations   of 57579
 
I would like to say .. I did read that very nasty and inappropriate comment you made to Lady. I even noted it to a few as it was a direct and dis-respectful commentary... and correct, I cannot locate the post as it is no longer ...

We don't have to like everybody in a group, yet it is correct to respect opinion and who they are as a human; usually when we feel a "disgust" towards another we are looking at an aspect of self that wants to be revealed.

Live long an prosper to all! :)

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To: diaperdaddy who wrote (50207)2/8/2019 11:34:42 PM
From: kdd999
1 Recommendation   of 57579
 
Absolutely best post of the year. I laughed out loud for sure at that one!!

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To: jargonweary who wrote (50215)2/8/2019 11:40:21 PM
From: kdd999
   of 57579
 
STOP IT or I am going to stop the car and bash both of your heads in and you can walk the rest of the way home.

Sorry I can only reply to one person, but YOU KNOW WHO YOU ARE!!

GROW UP.

(Please don't ban them, it is actually kinda funny. Reminds me of when my adult sons were 5 and 7 years old on the way to school every morning.)

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