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   Biotech / MedicalImmunomedics (IMMU) - moderated


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From: captcobra18/20/2019 8:16:14 AM
1 Recommendation   of 57542
 
Canton Fitzgerald initiates IMMU an overweight, price target of $28. 8/20/2019

benzinga.com

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To: captcobra1 who wrote (52162)8/20/2019 8:20:42 AM
From: Dietman
   of 57542
 
Lovely way to start a Tuesday

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From: Renmanco8/20/2019 10:04:17 AM
7 Recommendations   of 57542
 
Lots of anxiety here lately. Complaints about taking so long for re-submission and whether Behzad has the skills to run the organization.

First, if I were CEO of a biotech and received a CRL letter, I'd be damn sure to correct everything beyond mere acceptability and strive for better than expected....to show the regulators that I took the wrist slap as serious.

Second, Pehl came from Celgene, hardly a slouch outfit (though even CELG has had issues with filing for drug approvals) My take on Pehl---he lacked regulatory interaction experience and that was what we needed at the time; consequently, he couldn't appreciate the detail required to go into an FDA submission.

Third: Behzad. He moved swiftly to get rid of Pehl. He did have "experience" in dealing with biotechs through his hedge fund so I believe he figured he could at least set the barrier high enough for re-submission to insure no more screw-ups. AND, he put Charles Baum (CEO of Mirati and another large and successful Behzad holding) on the Board, no doubt to offer assistance in doing a correct re-submission. Losing a year in biotech is very dangerous and, in many cases, it can be fatal. I hope we will still have a competitive edge once the re-submission is done....but the jury is out as to whether "silly" will be a viable word until the evidence is further developed.

Like many here, I regret the past mistakes and I remain of the belief that Behzad has figured things out at long last and we will have a successful re-submission. If he fails gain, the game as we know it will be over and the asset auction can begin.

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From: Wildbiftek8/20/2019 4:08:00 PM
   of 57542
 
The SRPT snub yesterday may have something to do with today's price movement (and the hit to biotechs shares in general):

fiercebiotech.com

“The real driver(s) of the aytpical golodirsen CRL will continue to be a debate based on limited public disclosure of the granularity of facts, but the macro take home is clear in our minds—there is a regulatory “raising of the bar,” the analysts wrote. This could spell bad news for Sarepta’s other programs, namely its microdystrophin gene therapy that the Evercore ISI analysts consider the “major valuation driver of [Sarepta] stock.”
...
Sarepta’s recent communication strategy “on many elements has been atypical relative to traditional biotech company communication—yesterday’s press release [about golodirsen] is obviously just the most recent example,” the analysts wrote.


I'm not saying this reads through directly to IMMU's current situation, but there are some parallels to the situation with Sac. G. and a raising of the approval bar wouldn't generally be considered good news for IMMU. I still have high hopes for the ADC in general, but I'm leaning toward a later approval date than expected given this.

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To: Dietman who wrote (52163)8/20/2019 4:28:06 PM
From: JJINV
   of 57542
 
Lovely start... Terrible finish... Capt. B - Maybe you should buy some more...

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From: WawaDoc8/20/2019 5:26:24 PM
4 Recommendations   of 57542
 
I know I state the obvious. As long as there have been markets, there have been swindlers. For the 1,000s of years we have markets, the brightest people in the industry have been snookered. There are are some good crooks out there, now, and very sharp people getting it. Down a dollar today, someone made some bucks. I have a lot of this stock, I believe in the science. But I have said before the science is passing IMMU. I am most distressed by the friends and patients, I have lost to the greed and incompetence of our system. Is time to rethink how we do medicine In the US

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From: EagleRare8/21/2019 10:18:21 AM
   of 57542
 
Interesting share price chart. If you go for that stuff, we are at an inflection point.

finance.yahoo.com

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From: rodneyh078/21/2019 10:41:41 AM
   of 57542
 
Look and sound familiar...... “surprised “:

We are very surprised to have received the complete response letter this afternoon,” Sarepta CEO Dough Ingram said in a statement released by the company. “Over the entire course of its review, the Agency did not raise any issues suggesting the non-approvability of golodirsen, including the issues that formed the basis of the complete response letter.”

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To: EagleRare who wrote (52168)8/21/2019 12:11:03 PM
From: plhky3465
   of 57542
 
which way we going from here????

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To: plhky3465 who wrote (52170)8/21/2019 1:58:36 PM
From: EagleRare
   of 57542
 
I thought the share price would resolve itself in that triangular channel in October on BLA resubmission. Maybe that DS-1062 data release will materially impact the share price today though. We'll find out soon.

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