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   Biotech / MedicalImmunomedics (IMMU) - moderated


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To: bobbseytwins2001 who wrote (53624)1/11/2020 7:07:50 PM
From: TinfoilHat
4 Recommendations   of 58928
 
My ears are ringing! Me thinks multiple NDAs of unpublished data make for an anticlimactic bidding war should that data be spilled via press release prematurely. Remember we are not only courting suitors but also CEOs. Calling Pascal Soriot....

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From: Renmanco1/12/2020 10:01:11 AM
10 Recommendations   of 58928
 
Approval is expected which may lead to a "relief move" of perhaps 20%. When we get approval is anyone's guess, though I'm thinking within 2 months as our "issues" will not require a full re-do by the FDA of all things drug-related. But that's only step one......

I'm also of the opinion that Behzad knows full well what he has in the lab perking away and, as a pretty savvy hedge fund manager, he also knows how best to lay out the groundwork post 132 approval to maximize shareholder value, of which he is by far the largest owner. He can get through "approval" without hiring a CEO (and I would think any CEO worth hiring would know the back story of IMMU up through his hiring date....and, consequently, may not take on a career enhancing or destroying position unless and until approval gets done).

If what is still to be filed with the FDA are multiple NDAs and if SG is truly a platform drug which can serve as the foundational agent for several unmet indications with large sales and profit potential, I'm quite sure that Behzad is smart enough to evaluate the next 3-5 years for the company, determine an appropriate valuation along that pathway and decide whether to take a buyout offer at what he deems to be an acceptable discounted fair value or, if that is not forthcoming, he'll likely opt to "go it alone," put in place a name CEO and see what happens.

The Baker Brothers have a very, very long-term relationship with Seattle Genetics which has appreciated by about 22% per year going back well over 15 years. I'm sure Behzad knows this and that sort of performance may be his minimal measuring stick as to whether to sell out or ride the wave. In looking at a 3-4 year IMMU chart, we look to be about mid-way between $12 and $27 (recent low and high points) and if Behzad cannot see more than an annual appreciation potential in excess of 20% per year from (let's assume) $27 as a base, he'll probably opt to sell the company.

The final possibility is that a major portion of the "on the back burner stuff" will be filed with the FDA over the next 1-2 years and these applications will be collectively evaluated by the market as really big deal drugs (with 1-3 holding blockbuster potential, including 132 in mTNBC) and Behzad thinks this can provide 3-5 year returns which may again lead to those "silly" valuations about we speculated two or so years ago.

This latter possibility is why so many "blue chip" institutions have held on through all the challenges and torment of the past 18 months. I think we'll begin to know a lot more still this quarter.

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To: Renmanco who wrote (53631)1/12/2020 8:29:56 PM
From: erickerickson
4 Recommendations   of 58928
 
OK, I'm feeling bit snarky tonight, so take this as humor...

"I think we'll begin to know a lot more still this quarter."

How, exactly, is this different from the last, oh, decade or two ;)

About a year ago come to think, I was thinking: "What could possibly go wrong?".

I really do think this time it's different to be sure, but we're in the 9th inning. I really need IMMU to hit the ball hard to continue being optimistic.

Speaking of optimistic, when I'm feeling that way I wonder how closely they've been working with the FDA. It'd be really nice if at least part of the delay was working closely enough that much of the re-submission is pro-forma. I realize the inspectors can't just stop by, have a cup of coffee and say "approved". OTOH, if the inspectors are at least somewhat familiar with what steps have been taken it might shorten the time it takes to evaluate the manufacturing parts of the re-submission.

I can hope anyway.

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From: Renmanco1/13/2020 8:08:33 AM
2 Recommendations   of 58928
 
Reminder: Here is what is currently being re-examined:

“The issues related to approvability in the CRL were exclusively focused on Chemistry, Manufacturing and Control matters and no new clinical or preclinical data need to be generated."

Let's not forget that getting this right will/should make future submissions somewhat easier as the CMC trio will have already been approved per the current submission and just updated clinical drug safety and efficacy data needs to be added unless, of course, future submission specifics will require new CMC procedure inputs.

Once IMMU's team gets this all done (finally) correctly this time, they will have enhanced their skills for future submissions....at least that would be my expectation.

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From: EagleRare1/13/2020 9:34:31 AM
1 Recommendation   of 58928
 
I guess the inspection did not go well?

How long until we see the 483 forms?

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To: EagleRare who wrote (53634)1/13/2020 9:50:19 AM
From: KeeptheFaith
   of 58928
 
SGEN also down 7% and IMGN down 4%. It still leaves me uneasy.

- KTF

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To: EagleRare who wrote (53634)1/13/2020 9:50:25 AM
From: trickydick
   of 58928
 
Anyone know why IMMU is down $1.50? Plus very heavy trading at the opening. I'm still looking but haven't found out why we're down so much. Anyone??

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From: sysiphus1/13/2020 9:54:28 AM
   of 58928
 
Be nice to see a management comment that they don't have any knowledge about cause for unusual price movement, if true.

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To: trickydick who wrote (53636)1/13/2020 9:55:22 AM
From: csbiomajor
   of 58928
 
whatever it is it's not about IMMU specifically

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To: trickydick who wrote (53636)1/13/2020 9:59:57 AM
From: Rob_StCloudFL
   of 58928
 
Looking at Yahoo - CYDY reported that it will apply for BTD for its leronlimab drug to treat TNBC based upon encouraging early results. Maybe that is it?

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