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   Biotech / MedicalImmunomedics (IMMU) - moderated


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To: bobbseytwins2001 who wrote (52493)9/14/2019 6:41:23 PM
From: stockdoc77
11 Recommendations   of 54968
 
The institutional ownership certainly has to be counted as a positive, but on the flip side, many of us here built huge positions when there was very little institutional ownership. Where were all those brilliant investing minds in 2016? One cannot certainly rely on that metric alone to determine the wisdom of owning any given stock.
I do think that there was a fair amount of risk here in the last few months, but events of the last few weeks have resulted in me reducing that risk assessment. I think the stock looks good into next year. Which is why I bought back most of what I sold in June about 10 days ago when we were down in the 12's.
If IMMU was 5% of my net worth, I would not be quite so involved in its ups and downs nor quite so emotional about it, but like many here, it represents the bulk of my life savings, and I'm too old to rebuild that if this were to fall apart, so even a 10% chance of failure gives me heartburn.
I do think that the the willingness of some on this board to give B a pass on the CMC failure drives me up a tree. Especially given that his whole shtick was he was the guy to trust to get this right.
The upside of this stock is still tremendous, and DS 1062 falling off has improved that prospect. Frankly, I think if we get TNBC approval and BTD in bladder we could go over 40 dollars.
Rationally speaking, we should get TNBC approval, but rationally speaking, we should have gotten it 8 months ago. Everyone else with BTD filing for AA gets approved, and we somehow manage to blow it up. That still makes me angry.

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To: bobbseytwins2001 who wrote (52493)9/14/2019 7:26:00 PM
From: ladyPI
4 Recommendations   of 54968
 
Curious how you know what “Dave” holds? BTW, welcome back. We missed your informative posts. I also meant to thank you for the compliment (implying that anything I might say would have folks buying/selling - millions of dollars worth of stock). I haven’t sold a share. Anyone reading this that sold as a result of negative management comments, you do not belong in the market if you trade based on anything a total stranger says. That being said , if any of my sheep are still on the board, immu is a BUY. I’ll expect to see heavy volume Monday.

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To: bobbseytwins2001 who wrote (52493)9/14/2019 7:41:09 PM
From: kdd999
1 Recommendation   of 54968
 
Thanks for that accounting. Maybe it will be the long-awaited short squeeze. Exciting!

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To: ladyPI who wrote (52496)9/14/2019 7:42:40 PM
From: Dietman
   of 54968
 
Good to hear you positive lady

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To: Dietman who wrote (52498)9/14/2019 9:14:54 PM
From: ladyPI
1 Recommendation   of 54968
 
Never lost my optimism about 132

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To: stockdoc77 who wrote (52495)9/15/2019 8:00:48 AM
From: erickerickson
10 Recommendations   of 54968
 
Doc:

re: "some on this board to give B a pass on the CMC failure"

To me it's more a matter of how to go forward rather than "giving a pass". I haven't been of the opinion that throwing the bums out and starting fresh with new faces was the fastest way to re-submission, I think it would have taken longer. I was surprised and disappointed with the CRL. I'm surprised and disappointed that it will take until at least October to re-submit, my initial thoughts were that it'd be much faster than that.

Yes, Captain B. bears some responsibility for those disappointments, whether through lack of oversight, or because the FDA blindsided everyone (remember it was around the shutdown), or because some of the board's hires annoyed the FDA, or, as I suspect, the board hired people who blew it. The management style "hire good people and get out of their way" can backfire.

All that said, I want the shortest path possible to resubmission/approval, and I do not believe that would have been accomplished by wholesale slaughter at the top level. So what could Captain B. do that would get you down from that tree? ;) I want him to bend all efforts to getting it right this time, no quarter, no excuses.

Of course if there's another screw-up I'll ask the entire board to jump off a cliff.

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To: bobbseytwins2001 who wrote (52493)9/15/2019 4:16:15 PM
From: TinfoilHat
2 Recommendations   of 54968
 
Interesting find Bob, glad to see you back as you're one of the only posters who I pay close attention to.

However one additional perspective on shorters is a potential lack of accurate info by their scientific advisors.

Take for example G1 Therapeutics, GTHX. I see they will be presenting oral data at ESMO on mTNBC, and their early PFS data looks quite impressive, if memory serves around 8 months.

At ESMO GTHX will present OS survival of their drug added to chemo in mTNBC, and the title of the talk tips it's hand to state that OS will prove to be better than chemo, thus the oral presentation. Could it numerically prove to be better than our Ph2 data?

My two cents, ether bong or not, is that this is a near-term risk for our beloved IMMU, but only if scientific advisors and investors alike don't understand GTHX's trial design in its intricacy.

Note the GTHX mTNBC data includes treatment naive patients. Prior lines of treatment were 0-2, vs IMMU-132 showing stellar results in 2-12 prior lines of therapy. Totally different ballgame to compare PFS & OS in 0-2 lines vs 2-12 prior lines of therapy.

Plus the GTHX includes ~75% of patients with ECOG scores of 0 whereas the script is flipped for Sacitucumab Govitecan, ECOG of 1 was in the ~75% range. Don't get me wrong, there seems to be solid benefit to the GTHX drug in mTNBC when added to chemo, my question is what will be the impact when it gets added to IMMU-132?

All this to say, to those IMMU hedge fund institutional shorters out there thinking you're smarter than me and bob and a handful of others here, I suggest you consider hedging IMMU by buying GTHX.

On that note, I suggest Bezhad considers acquiring GTHX, or vice versa, seems like a ton of synergies between both of these companies, both from a pipeline perspective and mechanism of action of their respective drugs for combo considerations.

Go mu, thx.

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To: stockdoc77 who wrote (52494)9/16/2019 12:12:24 PM
From: weatherproof
9 Recommendations   of 54968
 
>>Any sense on the timeframe of how long it takes to get BTD after you file for it?<<

My sense is that if the data coming out of the ph II cohort which includes a larger body of CPI-refractory patients warrants it, IMMU will approach the FDA about BTD with that data. Since said data is available and ready to be presented at ESMO, I imagine this conversation has already happened and I believe the FDA will reply to the BTD request within 60-days. Just my sense of things.

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To: bobbseytwins2001 who wrote (52493)9/17/2019 7:18:07 AM
From: sogwap1
1 Recommendation   of 54968
 
"Can anyone imagine what might happen if the biotechs strengthen or good IMMU news breaks out?" So how do the shorts compensate for this ? The Class Action Law Suits start hitting the headlines again. Hang in there newbys, this happens everytime we start seeing positive momentum.

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From: TinfoilHat9/17/2019 5:13:37 PM
8 Recommendations   of 54968
 
Been trying to gauge what IMMU will present at SABCS this year given TNBC data has already been published, new trials with PARP inhibitors are still too immature to present. What on earth could move mountains?

Hoping this crack(pipe) team can help me dig up info to corroborate my suspicions, but from the looks of it, we have never yet presented OS data on HR+/HER2- patients from the Phase 1/2 data.

Bardia presented data on 54 patients over a year ago at ASCO highlighting PFS & ORR for IMMU-132 in late stage disease, and at that time 70% of patients were still being monitored.

Can someone help confirm that the OS data has never been published, or am I missing something?

All I can find is they aligned with the FDA on final scope for Ph3, but no publishing of OS data.

From the math of it, this number could be a doozy worthy of SABCS presentation...

Results: Fifty-four pts with HR+/HER2- mBC (all female; median age 54 yrs, range 33-79) were accrued between 2/2015 and 6/2017 (has data been published on OS since 6/2017?)
ascopubs.org

Take a midpoint of this timeframe, say April 2016, Bardia should have published OS data from this cohort at ASCO theoretically, no?

Keep me on my toes and point out the OS data from this cohort my friends, otherwise, let's see what Santa has in store for us this coming December.

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