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Lol....NICE.
We must be getting close, even if you shine a smidgen of light, they "all" scurry.
I was being sarcastic!!
Wait a minute...the who's who on this MB said that LL/UCLA have distanced themselves from NWBO and DCVax?
(72) Inventor(s):
BOSCH, Marnix, Leo; 1735 90th Avenue Ne Clyde Hill, WA 98004 (US)
GANJEI, James, Kelly; 4800 Montgomery Lane. Suite 800 Bethesda, MD 20814 (US)
POWERS, Linda, F.; 4800 Montgomery Lane Suite 800 Bethesda, MD 20814 (US)
LIAU, Linda, M.; 10418 Windtree Drive Los Angeles, CA 90077 (US)
PRINS, Robert, M.; 715 Haverford Avenue Pacific Palisades, CA 90272 (US)
What's unethical is running these RCT's, with large placebo groups for indications such as GBM and actually getting patients to participate in them.
Fortunately for patients and the medical community this is all about to change and much to your chagrin, NWBO will be at the forefront of these changes. And no, they will not have to re-do their trial.
You are completely out of step with Pazdur and the FDA
Um, I agree!
I suggest ALL that truly want to better understand the "delays" that NWBO has been up against, go back and listen from the 36:00 mark of Dr Liau's speech pertaining to RCT, ECA's, a well established control arm (n=1366) per Stupp protocol to compare against.
Turing Cold Tumors into Hot Tumors!!
Adjuvants (Poly ICLC) creating peripheral TCell activation with DC Vaccines...actually into the tumor! Why CI's aren't working...not properly activiating TCell activation.
DCVax will be the main immunotherapy platform used in combo with ICI's...hence, endless possibilities.
The possibilities are endless
— Michael Bigger (@biggercapital) April 14, 2022
100% agreed SI!
The next 4-6 weeks are lining up to be very interesting and it's obvious this long "quiet period" is coming to an end.
IMO we will have some news to talk about prior to ASCO.
GLTA
No he doesn't Doc!!
Lot's of nice catalysts all lined up over the 6 weeks!! Should be very interesting to say the least
Don't be a tease!
Interesting...Annals of Oncology getting a shout out from Dr Subbiah
🚨🥁Just in time for @AACR #AACR22 the final version is now OPEN access+ free to read 👉🏼 FIGHT-101, first-in-human study of FGFR 1-3 inhibitor pemigatinib in pan-cancer patients w FGF/FGFR alterations @Annals_Oncology @myESMO @OncoAlert #PrecisionMedicine https://t.co/u6UDoZbrWQ pic.twitter.com/KWfgSJ9geP
— Vivek Subbiah, MD (@VivekSubbiah) April 12, 2022
Hope you're still recommending DCVaxL to those you love!!
Seems to be alot of international approval collaboration going on
Accelerated, conditional, provisional or temporary approval?
— FDA Oncology (@FDAOncology) April 11, 2022
Mon 4/11 @ #AACR22, join #FDAOncology's #ProjectOrbis & #OCEProjectConfirm and international regulators to compare expedited approval programs, 12:30 pm CT.https://t.co/dQxKtGxIY5 pic.twitter.com/TrI307ig3s
Statistical Analysis Plan
A SAP also is prespecified before the start of a trial. It may be amended during the trial while the data are blinded but is finalized before the analysis is completed and the data are unblinded. The SAP drives the primary analyses of the analyzable data set.
The full data package (including the full analyzable data set, the full protocol,9 the full statistical analysis plan, and the analytic code) should be shared no later than 18 months after study completion (unless the trial is in support of a regulatory application).
https://www.ncbi.nlm.nih.gov/books/NBK286004/#:~:text=A%20SAP%20also%20is%20prespecified,of%20the%20analyzable%20data%20set.
The statistical analysis plan may be written as a separate document to be completed after finalising the protocol. In this document, a more technical and detailed elaboration of the principal features stated in the protocol may be included. The plan may include detailed procedures for executing the statistical analysis of the primary and secondary variables and other data. The plan should be reviewed and possibly updated as a result of the blind review of the data and should be finalised before breaking the blind. Formal records should be kept of when the statistical analysis plan was finalised as well as when the blind was subsequently broken. If the blind review suggests changes to the principal features stated in the protocol, these should be documented in a protocol amendment. Otherwise, it will suffice to update the statistical analysis plan with the considerations suggested from the blind review. Only results from analyses envisaged in the protocol (including amendments) can be regarded as confirmatory.
Changes to critical elements of the analysis (e.g., the primary endpoint, handling of dropouts) during a trial can raise concerns regarding bias, specifically whether the changes could reflect knowledge of unblinded data. Concerns are inevitably greatest when the change is made late and has an important effect on outcome. In theory, if such changes are unequivocally made blindly (e.g., because of data from other trials or careful reconsideration) they should not pose problems
http://onbiostatistics.blogspot.com/2020/01/pre-specification-and-statistical.html
Do you think the DCVaxL trial failed?
If so, did it fail on all endpoints?
If it did not fail, what aspects of the success of the trial will you object to?
TIA
You should probably check with Ex on this!
In thru the nose, out thru the mouth...just breathe, breathe deeply.
All your concerns and consternations will be addressed soon enough!
Might have some interesting info
📢🥁Just 1 week more for the MAJOR Symposium👉 "Defining Clinical Benefit: Accelerated Approval in Precision Oncology" session in @AACR #AACR22
— Vivek Subbiah, MD (@VivekSubbiah) April 5, 2022
Moderated by @GautamMehtaMD @FDAOncology Speakers: FDA, patient advocacy, academia & yours truly🎯@tmprowell https://t.co/FZcRMK7IP3 pic.twitter.com/EyHayyGflc
I would look at the Mayo Clinic
Ironic that you speak of disingenuous...quite laughable actually.
We shall see who the "fools" are and who will throw tantrums in spite of overwhelming positive TLD and acceptance by the medical community.
Again Doc...pat em' on the back and say good luck.
The guys gets his rocks off on this MB for some reason
Anemic Volume
Nothing less than $40 pps but there will be no buyout unless it's an absurd amount
Completely incoherent, belligerent statement
I will work on that CHG!!
and you didn't have incessant Yahoos' parading around the boards of CLDX and IMUC 24/7 claiming it was a scam.
Pls post link where NWBO PR that their trial failed.
As to the old man in the watchtower...we shall see if his value is proven.
As to "the blog" it has more information and DD put into it than you could ever muster from you parents basement.
Your rants are tired, old, repetative and lack any substance but at least you got your A Game on!!