To: JohnBeach who wrote (52180) | 8/22/2019 12:19:35 AM | From: duwhee | | | I'm just glad the G's are not attending on the IMMU dime. They'd bask in whatever accolades they could while delivering no return to IMMU on the investment of the trip and then come home with nothing more than the "Hello My Name is:" badge. |
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To: EagleRare who wrote (52181) | 8/22/2019 8:35:50 AM | From: TinfoilHat | | | To stem the tide by drawing from the ether circuits, the Daiichi data to me is a super positive.
Either we are given a chance to showcase our safety profile vs theirs, and thus a comparison of linker technologies - remember DS1062 had a couple stinkers in prelim data whereas IMMU 132 has been recognized by KOLs to be sufficiently safe to consider combos with PARP inhibitors. An investigator from Harvard started his own trial for heavens sake, that is a strong signal. At ESMO don’t look at efficacy, look at safety of DS1062 to compare with Sacituzumab Govitecan.
Or, the Daichi data is great and we get a boost from having comparable technology. I have seen this countless times in recent weeks.
My reading of the stock price tea leaves is this has been a technical drop to the 13.70 level area to test support, likely stoked by the FDA wildcard. However, Patient advocacy groups will be hellbent if IMMU132 doesn’t get approval at the next go.
Remember, Tecentriq for TNBC got approved in March in the US. Patients who have recently started will need an option soon, and more than 50% are not eligible for tecentriq given lack of PDL1 expression. Patients need options asap, we have one on the shelf. Btw, Gottlieb may have had his thumb on our last application, and he has now been replaced by a guy from the NCI. We are on the glide slope...
Final toke from the ether signals for today: I think doright is Goldenberg and Bobbsy is Bezhad. That’s at least who I picture when each posts, keep up the good work you two. |
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To: TinfoilHat who wrote (52186) | 8/22/2019 12:37:57 PM | From: CelebrityEquity | | | Let's acknowledge....you did write *TOKE*
Final toke from the ether signals for today: I think doright is Goldenberg and Bobbsy is Bezhad. That’s at least who I picture when each posts, keep up the good work you two.

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To: JohnBeach who wrote (52184) | 8/22/2019 8:27:45 PM | From: KeeptheFaith | | | JB or anyone, care to share baseless speculation or conspiracy on why it is not public yet? Just for fun in these news-depraved times. I’ll be.l boring and say administrative error by conference host. (Instead of a Fuerstein-inspired fiasco) - ktf |
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From: JJINV | 8/23/2019 12:45:54 AM | | | | They are not shy about hiring! Lots of activity. Interesting too the IT interest... I would assume as part of the overhaul of the process, new software systems in place, and that takes time... tick tock
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To: JJINV who wrote (52190) | 8/23/2019 7:45:33 AM | From: erickerickson | | | "They are not shy about hiring!"
They weren't last time either. I was all excited last time by the hiring as a show of confidence. Which it was, even if misplaced. I'm not that excited this time, even if it does show confidence. "Once bitten, twice shy" comes to mind.
I do wonder what the head count now is .vs. January just before the CRL. About the only insight we have into what happened personnel-wise after the CRL is that they went to significant effort to keep the sales staff from bolting. And made some changes at the top for sure.
Other than that, we don't know much. My uninformed guess is that they made an effort to keep people they considered key from leaving and otherwise left positions open those who decided to move on. Now they're filling them back up again toward pre-CRL levels.
I have no evidence one way or the other if they "rightsized", but frankly I rather hope not as it would make hiring now more difficult.
So my guess is that now they're betting that they'll have a need (speedily I hope) for full staffing again and are starting to staff toward those levels. Let's claim that's true for a second. My (again guess) is that when the approach those levels is the time they're expecting the CRL, hope it's before Christmas, and I hope they're right this time.
That said, I don't have access to their personnel records so my guess is as good (or bad) as anyone else's.
And this is a job posting. The absolute minimum I'd guess is that it'd take a month to fill, and that's if there's an ideal candidate beating down the door. 2-3 months wouldn't surprise me at all, especially for the senior positions. Although what you can tell from job titles is anybody's guess. In my business, "Senior programmer" frequently seems to require "5+ years programming experience", a mere child IMO not "Senior" ;).
Just for yucks I tallied up the openings by when they were posted:
Last week
| 8 | 1-2 weeks ago
| 12 | 2-4 weeks ago
| 8 | 1 month ago
| 18 | 2+ months ago
| 17 | So they're certainly not thinking they're going to close the doors any time soon! Mind you I'm encouraged, just not giddy this time around.
Anyway, enough. I have to go build some drawers for my workbench. |
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To: KeeptheFaith who wrote (52189) | 8/23/2019 9:39:42 AM | From: ladyPI | | | Speculation - stock was already down 2 percent that day and news not as good as anticipated so letting stock get back up before 9/10 reveal |
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From: kdd999 | 8/23/2019 3:20:31 PM | | | | Link to article on N of 1 trials, not only for already approved drugs, but future trials of new drugs. When done in cloud based setting, this has potential to greatly reduce cost vs RCT trials, plus it can help individual patient determine if a drug works for her. (These are individually blinded trials, but outcome is provided after the trial to each individual. How many of us with chronic diseases have argued with doctor that a medicine does more harm than good for us as individuals, even though it helps a percentage of the population as a whole.) They can statistically collect all the individuals results to determine overall population efficacy.
I think this might be a solution for emab lupus trials (although it still requires the cost of mfg the drugs). When I read this article, I was haunted by the pleas of the woman in our lupus trials who was noticeably helped by emab (she was able to go back to work) but had to go back to a life of misery after the trials ended.
The article says this may be a better way to test orphan drugs where it is hard to enroll enough patients.
the-scientist.com |
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To: KeeptheFaith who wrote (52189) | 8/23/2019 3:39:26 PM | From: JohnBeach | | | Hmmm, administrative error is pretty thin. The other Daiichi compound, U3-1402, has an abstract, as do most of the other oral presentations. Although there are a few others I found missing abstracts. I don't know enough about these things to come up with a viable theory.
But, it seems to me that the market has assumed the worst, that the 1062 data didn't fall apart. I think it's unlikely that the results could continue their incredible trend. They had 100% response from the 8mg cohort, albeit only 4 patients. Still 4/4 is jaw dropping, especially measured against the increasing effectiveness as they escalated the dose, and they aren't done escalating yet.
But, for perspective, consider the response from the immunotherapy Keytruda. They had nsclc results a year or two ago that stunned - 42% response in treatment naive patients, and 23% in previously treated. Is it really plausible that Daiichi could have a compound that is yielding near 100% response in previously treated patients? I don't think so. There must be a caveat, maybe a safety signal, maybe a quirk in the way these scans are being read. Either way, it's BS that they didn't release the the abstract. |
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