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...I think a book needs to be written...
SEC Charges Microcap Fraudsters for Roles in Lucrative Market Manipulation Schemes
https://www.sec.gov/news/press-release/2018-182
I think there is a typo in the transcription.
"...SOME..."
"...so we..."
I clearly hear "so we".
"...we haven’t unblinded yet, so we don’t know yet who got the treatment..."
M
1.5 2018 blinded data update from the Spring refresh. Post- journal publication, pre- data lock.
I recall RKMatters making the November 2018 call. How can she be so right on matters in the more distant future?
Impressed. Even moreso if I recall correctly.
In particular, the results of this study show that IDH1 mutant gliomas are less vulnerable to radiation-induced DNA damage which draws into question the efficacy of radiation therapy for this subset of tumors.
NW Bio Announces Completion of $12 Million Financing
1:39p 12/4
If we're still playing 20 Questions...
Tilt, is our new investor
Amazon?
Go Big.
An
tiss
a
pay yay
shun...
Thank you TheFollower.
The GBM Heroes meeting was held "...the opening night of the SNO Annual Congress...", Thu. 11-16 at 5:30p in San Francisco.
https://www.curetoday.com/gbmheroes
I wonder what time this was today or yesterday.
GBM Heroes Honored By CURE
https://www.curetoday.com/articles/gbm-heroes-honored-by-cure
I'd love to see how others define a Site Initiation Visit. Per this one:
"An SIV or Site Initiation Visit is a monitoring visit that takes place after the Site Selection Visit. It is a visit that happens after the study sponsor has already selected the site for participating in a clinical trial."
EDIT:
https://medium.com/@TheRealDanSfera/what-is-a-site-initiation-visit-in-clinical-research-bb1b5653a53a
/EDIT
It would seem this type of meeting occurs early in the trial, which has me wondering if it's for the *next* trial...
Agreed H2R.
A couple of other observations
- This meeting was scheduled in July. They've know this long that they wanted to have it on this date.
- it's not a standing once/month or once/week meeting
- there are no others like it for the immediate preceding or following month
- there are similar meetings, some with specific manufacturer/product names, many without.
The "Who Should Attend" list does *not* call out any particular individual or company.
This is who should attend
Directors, senior scientists, project leaders, research directors of:
Immuno-oncology, vaccine development, oncology, molecular medicine, immunobiology
Random thoughts:
1. The list of companies under "Who should attend" @ SMI is an attendee list from last year. It's misleading the way it reads, but if one registers at the site, last years' attendee list (by company) can be viewed. I seriously doubt it has anything to do with a LP-NW spat. WIM is listed as an attendee in 2016.
2. A new raise doesn't necessarily mean they have already burned through the last one. If they reevaluated expenses to determine how to keep the power on for life support while hospice is watching over the aging data, perhaps they'd rather raise now than at the last minute.
3. I doubt the raise had anything to do with funding an application. Surely that is foreseeable and can be forecasted.
4. Thanks to both sides for helping me to on one hand "connect the dots" and on the other hand understand those connections can be unstable... :)
5. With apologies to those who are already in too deep, for those who are contemplating taking more risk beyond what they typically would, please carefully reconsider.
So you searched for:
Noticed same starting a week or two ago.
"DCVAX" search term showing up on google search for the last week under a hit for "Recently Updated Advisory Committee Materials - FDA". Can't find where it is buried.
Also, Dr. Bosch mentioned 2 publications, the other for the direct ph I trial.
If they have good news to share, this will indeed be an "inflection point" (as CDRD put it from his call with Les).
- end of P3
- "the paper"
- "trial at UCLA"
- "a trial in Germany"
If they are verifying anything, aren't they making sure a patient's data doesn't get thrown out for non-compliance to the protocol?
"The Trial will reach data lock when the threshold events have been reached and the quality control checking has been completed for both the PFS and OS endpoints."
I find the versioning of the presentation filename interesting. v0.anything is usually reserved for any number of versions that precede the first final version. I was half expecting to see that file replaced with a correcting PR.
Without a correction, that's as final as it gets, which makes one wonder if there was something Dr. Bosch was waiting on to include...
Wishful thinking...
Lazarus might say they are crossovers.
"Why a $475,000 drug price tag isn't expensive"
Never thought I'd hear that so soon.
Good for us.
In addition to that key word "minimum", I think we are too quick to use "2" to predict the future. While the Dr. uses "currently" when referring to the rate, we don't know if 2 is an approximation over 24 months or 3 months, and how many of those months include no events.
"approx 2 OS events per month"
"it turns out that the death rate at this time is lower than anticipated"
So he anticipates the threshold to be reached, and that is based on past performance and not on knowledge that 2 subjects are about to event.
That said, I don't doubt OS threshold has been more than reached. As a secondary endpoint it may not warrant a PR.
... or a Press Release prior to the conference like we saw with ASCO....
Is statusing a trial *material*, or simply newsworthy?
"would the company even know"
Jokes aside, to what extent is the company "blinded"?
At a minimum I'd expect "...neither the subjects nor the researchers know which subjects are receiving the...treatment...", but they've also stated "The Company has been blinded at all times, with no access to any data in the Phase III trial, and will remain fully blinded until the trial is completed. " (Aug 2014)
If that is the case how can they know 90% have been treated with DCVax-L or that 100 are still alive?
"...some long-term GBM survivors treated with DCVax-L at UCLA. They include: Jennifer Sugioka, a 17 year GBM survivor; Brad Silver, a 14 year GBM survivor; Elijah Luyten, MD, a 10 year GBM survivor; Gallia Kistler, a 6 year GBM survivor; and, Jamil Newirth, a 6 year GBM survivor."
http://jeanninewalston.com/blog/brain-cancer-updates-long-term-gbm-survivors/
"which we finished... 3, 4 months ago..."
From the Keyoumars Ashkan video, which as some have pointed out was posted Jul 18.
The video description says the presentation was part of "The Brain Tumour Charity's Nurse and Allied Health Professional Study Day", which this year was held 19 May.
So Europe could have completed in roughly, judging by the speech, January or February.
Any significance to this?