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The attachment to which you refer:
https://downloads.regulations.gov/FDA-2019-D-4964-0065/attachment_1.pdf
from
https://www.regulations.gov/comment/FDA-2019-D-4964-0065
"I do not think this means the world is ending."
Alrighty then. While I've only validated 7 of the 10 are not matches, I've also folded the list and tucked it back into its hidey place.
I'll keep it close by, as I think I'll be referring to it again when TLD is released.
"That’s twice in 24 hours I agree with you."
<checks against personal list of "Top 10 Signs These Are The End Times">
"At the present time, the Society for Neuro-Oncology is planning to hold the 2021 Annual Meeting in-person... any changes to our plans will be announced should a virtual conference become necessary."
I think someone just got carried away with "on-site".
anecdotally, seems like results are being posted at a faster pace than in recent history.
maybe someone opened the floodgates on the backlog...
NDA's survive any changes in personal or professional status.
There is no reason to think Dr. Liau has any aspirations to leave academia for corporate life.
lrdpdx77,
Any relation to hansm7777 ???
"...It is anticipated..."
NWBO fingerprints all over this one too!
;)
Visiting family in Reno. We don't get atmospheric rivers in Wisconsin. :)
"...I believe someone already posted a link to that report...."
if I am not mistaken, that as the HTA report, not the MHRA report.
Regarding the Streeterville Capital financing described in the 03/05/21 8-K, we're set to begin $1mm/mo payments on that loan here in a couple of days.
Any ideas on where that comes from?
Orbis
Feb 16 2021 FDA grants priority review to Amgen’s Sotorasib. https://investors.amgen.com/node/30871/pdf
Sept 13 2021 “Amgen’s first-in-class medicine Lumykras (sotorasib) has become the first new cancer therapy to receive Conditional Marketing Authorisation for use1 across England, Scotland and Wales by the Medicines and Healthcare products Regulatory Agency (MHRA) under Project Orbis.”
https://pharmafield.co.uk/pharma_news/amgens-lumykras-gains-mhra-approval-under-project-orbis/
"combination phase I trial for rGBM "
The one with DCVax-L in the Active Comparator group?
"“Active control” (or “Active Comparator”) means that a known, effective treatment (as opposed to a placebo) is compared to an experimental treatment"
One definition, anyway.
LET,
"Wow... thank you"
I think you missed the point. WH specifically called our attention to the last paragraph:
Flipper44,
Regarding 5-ALA-guided resection, are you suggesting that these patients receive a photodynamic therapy that a) kills tumor cells and b) causes inflammation that our optimized DC's are attracted to?
(this is my last UnScientific WildAss Guess for the day.)
I think the reclassification idea can be traced back to Thursday, June 7, 2018 between 2:15 and 3:00p Louisville, Ky time.
Publication timelines from experience
06/05/2017 - Dr. Bosch discloses at ASCO publication of interim data is "in preparation" (earliest date I can find)
04/27/2018 - Received by JTM
05/07/2018 - Accepted by JTM
05/28/2018 - Published by JTM
Granted, we don't know how many, if any, journals they attempted to publish in prior to JTM.
And that was for blinded data.
At least a year.
"interim analyses in 2017 and 2018"
I suspect the author is confused about the differences between an "interim analysis" and an "analysis of... interim data". Study investigators did not compare trial arms to each other. Study investigators did not attempt to answer the primary research question.
They were not IA's.
Thus, the question of "stopped early if the experimental drug meets the primary endpoint" isn't a question.
I've taken the liberty of editing his Bio"
"Zhiyuan Sun is a Fool since April 2020."
[EDIT: already posted in 379077]
Re: six stages of various analyses and reviews
From Oct 5 PR and May 12 PR
1. Provide access to statisticians
2. Statisticians will analyze
3. Statisticians will summarize
4. Company, PI, Steering Committee, SAB, expert panel will analyze (and be thus unblinded)
5. announce results
6. publish results
From the 10K
1. Data Validation
2. Analysis by statisticians
3. preparation of result summaries
4. review of result summaries by same parties
5. publish
6. announce (including “public announcement will follow these processes”)
ASM: present tense “reviewed and analyzed”
ASM: “It’s really important that the review process be of the highest quality.”
ASM: “results need to go through to be reviewed and analyzed in a high-quality process.”
Sounds like we are on step 4 . Quiet period is related entirely to this process while they determine the results summary is correct and complete. A target date for step 5, be it announcing or publishing is, in my opinion, by May 31.
Before we know what has hit us, it'll be $990,000.
And then, who knows?
Dr. Liau's Preface in Glioblastoma, Part II: Molecular Targets and Clinical Trials
[EDIT: Buy this eBook! https://play.google.com/store/books/details?id=nMcpEAAAQBAJ&rdid=book-nMcpEAAAQBAJ&rdot=1&source=gbs_vpt_read&pcampaignid=books_booksearch_viewport]
Get your taxable income under $81,500 (married filing jointly) and you can enjoy 0.0% long-term capital gains tax.
I see a classic Loch Ness Monster with Baby Nessy kicker pattern.
RKMatters coming out of hibernation again is the confirmation signal.
* they suggest it's troubling that executives are being compensated substantially more in 2020 compared to 2019
* they find it more troubling that since then the stock has gone up and options are worth more
* they suggest that the order of operations - grant options, announce positive news, stock appreciates - is cause for concern
* they reference the exact same tables from the Proxy Statement that AF did, making the same suggestion AF did.
(not my claims, a summary of their communication)
"Don't provide any "oxygen" to AF and his crew."
Maybe I didn't think this one through.
"If you are a shareholder of Northwest Biotherapeutics, Inc. and wish to receive additional information, free of charge..."
By raising my hand to that, how am I encouraging those who are against the company?
I expressed an interest in the "INVESTIGATION". Here is why.
It's as frustrating as one of those unsolicited calls you get from "MICROSOFT SUPPORT". There seems to be no way to stop them. So one approach is to return the frustration. Answer the call, put it on mute. Tie up their phone system. Some will engage actively to make it a 30 minute phone call or more, which if scaled makes the potential benefit given the cost/inconvenience/frustration just not worth it.
So I responded. If 10% of shareholders responded once, that's 4,000 emails, phone calls, or voicemails. You don't have to complain. You don't even have to "comment" in the webform. I'll be happy just to receive their updates.
"Dose-dense" TMZ
First time I have heard the term. Googled "dose-dense" and didn't help me understand it any better.
Is there a reason LL would use "dose-dense" now?
Is SOC TMZ dose-dense?
Is dose-dense a form of off-label application of an approved therapy?
TIA
I monitor views of the Bosch 2019 ASCO video (which is displayed on the home page of nwbio.com) as a proxy for website interest/traffic.
Nothing scientific, and not even specific counts I have recorded.
But I have noticed that while in the past it used to take weeks to move the view stat by 100 views, it seemed it jumped by multiple hundreds in the last week or so alone.
agreed, and those are the percentages I had used until I compared them to the other columns. Weller's n=130 is 37% of (130+218) and the missing n=26 are not figured into the math at all...
That footnote re: Gilbert struck me as out of place. It reads in future tense and as part of a plan. I took it to have perhaps been copied from another slide deck.
Patient Characteristics versus Other RCT's
Added a column to Dr. Liau's slide 23. Behind on messages, apologies if already done.
The methylation status figures in her table totaled 100% even if "missing" was > 0, so that is what I used. Didn't see any info wrt over/under age 65 and residual disease.