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   Biotech / MedicalImmunomedics (IMMU) - moderated

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To: ladyPI who wrote (52496)9/14/2019 7:42:40 PM
From: Dietman
   of 58430
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 58430
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 58430

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 58430
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 58430
>>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 58430
"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 58430
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?)

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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To: Fitzhughlaw who wrote (52483)9/18/2019 5:19:41 PM
From: samcat500
   of 58430

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From: Tc-99m9/19/2019 5:22:54 PM
   of 58430
I noticed a 500,095 share transaction at 3:59 for 17.03. This is approximately worth 8.5 million dollars. There was also a 100,000 share transaction at 2:35 and a 113,000 share transaction at 2:34. Would these possibly represent institutional transactions or are those type of transactions kept private? I have also noticed that it is very common that large blocks of shares are often commonly traded at 3:59. Is there some sort of advantage for trading at the last minute?
Thanks for any possible explanations.

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To: Tc-99m who wrote (52506)9/19/2019 6:08:36 PM
From: sysiphus
   of 58430
Probably someone in Idaho doing some high frequency trading to make a few bucks late in the day.

Could be speculators / traders, noting the trading patterns of the past few days, that shows money can be made from the low of the prior day to the high of the next day - not always true for all stocks but easily spotted with an algorithm.

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