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


To: MFG ENG who wrote (49645)1/23/2019 5:36:07 AM
From: ghettogoulash11 Recommendations

Recommended By
bobbseytwins2001
drtom1234
erippetoe
idahoranch1
jargonweary

and 6 more members

  Read Replies (1) | Respond to of 63282
 
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." Nevertheless, your informative and acutely specialized analyses do unveil the rigorous, almost mind-blowing specifications involved in getting this drug to the market.

* according to trusted sources



To: MFG ENG who wrote (49645)1/23/2019 7:41:52 AM
From: JohnBeach17 Recommendations

Recommended By
alwayshope
bnutman
bobbseytwins2001
captcobra1
diaperdaddy

and 12 more members

  Read Replies (2) | Respond to of 63282
 
MFG ENG. Your input would have been helpful a month ago. Now, you are just pounding a drum. Everyone knows now that the CRL issues don't involve the items in the 483. 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. Last night you took the time to write 3,088 word post on the subject.

Why?



To: MFG ENG who wrote (49645)1/23/2019 9:39:21 AM
From: jargonweary6 Recommendations

Recommended By
bobbseytwins2001
diaperdaddy
JohnBeach
quantumup
urslor

and 1 more member

  Read Replies (3) | Respond to of 63282
 
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. 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? Just curious.



To: MFG ENG who wrote (49645)1/23/2019 11:45:31 AM
From: JJINV  Read Replies (2) | Respond to of 63282
 
"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.

Would really like to see the actually CRL, and a complete response by IMMU magmt.

Sooner than later.