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I still doubt no SAP had ever been submitted.
The IA is much less detailed than an actual final analysis. All they look at is a basically TLD. While the SAP has to nail down all the secondary endpoints.
As Senti's clipped post said, the "DMCA charter" would provide additional information for stat analysis. Who do you think these additional details were provided to, and why?
Ok then Im going to be as clear as possible too for we do not understand each other
Its common basic knowledge that the sponsor handles his government trial websitepage. Its also commonly known that the EMA, after being updated with trial protocol and endpoints by an EU member, handles the EMA website and not the medical sponsor.
In my view, you have not addressed the points which I posted before:
1. It's highly unusual, at least I have never heard of it perhaps you?, that a biotech company does add its endpoints to its page on clinicaltrials.gov, but does NOT have a plan in place that describes the planned analysis of the clinical trial they are conducting (aka the SAP).
Thus in other words NWBO did NOT have an SAP in place but did communicate endpoints. Again unusual since the study is open-label right
the statistical analysis plan should be finalised before the unblinding of study data, or in the case of an open-label study, before the conduct of the study.
“(3) For each submission of partial results information for a clinical trial, as specified in paragraph (d)(1) of this section: (i) If any amendments were made to the protocol and/or statistical analysis plan as described in § 11.48(a)(5) since the previous submission of partial results information, the responsible party must submit a copy of the revised protocol and/or statistical analysis plan”
I'm not exactly clear what you're asking...
Thanks,
I know what a SAP is I happen to know my way around FDA/NIH regs concerning submitting a SAP. I do not recall ever any biotech adding and editing their endpoints to the clinical trial website page without having it officially submitted to the FDA at the same time. Nope don't know any, perhaps someone else here knows any other biotech who did that?
Yes I know you cant do an IA without an SAP, but perhaps you should chance that you cant do any without one officially being submitted with the FDA. Cause there was a trial protocol (duh, you cant start an official FDA-certified medical trial without one) and there were apparently (un)?official endpoints (as still shown on the clinical website), BUT the latter... not officially submitted is that what you are saying?
Unless of course the endpoints as shown of the clinical trial website are submitted there without a plan to unblind the data and work towards those endpoints. If that is true then that is also unprecedented for a biotech.
It also goes through changes as the trial evolves
senti stupid question but,
If the SAP endpoints were unknown and only first submitted in 2020 just before data lock, then why did NWBO fill out
https://clinicaltrials.gov/ct2/show/NCT00045968 in 2016 (?)
with the endpoints
Outcome Measures
Go to sections
Primary Outcome Measures :
The primary objective of this study is to compare progression free survival from time of randomization between patients treated with DCVax-L and control patients. [ Time Frame: Time to tumor progression or death ]
Secondary Outcome Measures :
The secondary objective is to compare overall survival and time to disease progression between DCVax-L treated and control patients. [ Time Frame: Until Death ]
AF did not do anything this time its the whole market especially nonrevenue small caps. I thought biotech already had their portion, but they all are down today look at the XBI
By attributing any price pressure to AF we are assigning away too much power to the Fartstein. He is a nobody he is not able to move any price not even of his 1995 Honda Pacific
Techs crashing hard tomorrow? Hmmm, you may be my contrarian charm.
yes there is a huge head and shoulders on bitcoin year price taking it back to $ 22k, is my prediction. Luckily I dont see small caps bio much affected since they already were taken down a lot over the last months
I am sure I will hear Thursday, if the impossible should occur, that NWBO forget to PR TLD this week and NEJM forget to publish.
It does explain why the company seems so hellbent on not releasing TLD until the last possible moment before BLA filings/approval.
lol by all means Im more than happy too, but I do believe we are in for a big correction soon
You and your buddy exwannebe are wrong on this MB, Brian Lane, DI from NWBO, and Harvard Law (which I quoted in my long review on the subject a few weeks ago) are correct. So I agree with MB and I quote him
stop the … bullshit
MB on Twitter
If a fail, gotta be disclosed within four days. That train has left the station many moons ago. $NWBO #GBM as an aside Brian Lane is top Counsel for $NWBO and is one of the top securities lawyer in the country. He used to work for the SEC. #DUMBMEDIA stop the … bullshit
But its good to know ex knows better lol
Is this one of those things that gets everyone revved up over the weekend, but by Monday morning becomes an Emily Latilla skit?
well one thing we all can I agree on. If NWBO would again not adhere to SEC rules about timely submitting 10k/Q, as they have in the past, then an uplisting will be out of sight for sure.
I think they will delay the 10K as much as they can in anticipation of TLD/Publication and March 31 is the last day available to submit 10K apart from the option to request an extension of the deadline for 10 working days
I don't think they want any unauthorized delays anymore in anticipation of uplisting.
thats right
there will be no 10Q for Q4, next will be the 10K for all of 2021 including Q4 and this will probably be submitted on March 31 like last year
The canceling by Bosch for the Glioblastoma Drug Development Summit and now the announcement of SOS of a pending new article (presuming he is in contact with NWBO management) signals to me that we are yet in for another wait before TLD + publication. I can not imagine it will be later than Q1.
I can't imagine how LP can say in ASM this year if there is no TLD.
Lol haha
One can always divorce and find a new wife (or husband) but try to find a new good barbar ai ai ai lol
ooh horrible I know that one too. They tell me you said Topline data in 2020, in June, Sept, Dec and now you say Jan, Q1. Come to think of it the world is filled with Exwannabees arrrgggg lol
Im not aware of any such bet but if there was one he lost and he paid for steaks its that simple.
Im incredible happy I never touted NWBO as an investment opportunity to anyone tbh
You are treated to steak dinner if they become millionaires on your tip and feed you complaints and whining every day when it looks sourer and heads south. And with NWBO that is a lot of days of crap and not worth any steak
lol people you recommended NWBO to are now your park bench neighbor and refuse to talk to you?
Joan Lappin's articles in the past did have an enormous impact on the SP taking it from 1.45 to over 1.80. That impact has probably subsided now since everyone knows it does not last and what she predicted came not into fruition in the timeframe she predicted it would.
its not very difficult to guess why this is taking so absurd long, SOS takes a good stab at it
https://smithonstocks.com/northwest-biotherapeutics-fda-statement-regarding-use-of-external-controls-in-clinical-trials-is-a-huge-positive/
exactly thanks Flex
I have not misused anyone's email give me a break.
Hey Flex and thank you good morning to you too
You are right its up to the registered author to delete an account with NREJM. My mistake
You may delete your account at any time by logging into your account and choosing the “delete my account” link on the User ID/Password page.
It's also been stated that the lead author should be LL.
The NEJM Author Center provides an array of informational resources to help guide you through the manuscript submission, review, and publication process. Learn about:
Editorial policies
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1) Has Dr. Bosch submitted previous articles to NEJM, or would this be his first.
thanks
but a little too many holes for it to imply an impending article
I will guess no publication in the NEJM in H1 2022 despite this great find by dennis that Dr B submitted it.'
Look,
I personally dont think that https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-018-1507-6
was offered to NEJM by Liau, Ashkan and Bosch before for the simple reason that NEJM is not particularly fond of publishing interim blinded trials.
Bosch only published 4 times before https://www.biomedcentral.com/search?query=author%23%22Marnix%20L.+Bosch%22 none of them were in NEJM
I cant rule out the account was created prior to submitting the DCVAX L article but I hardly doubt it. So there is no guarantee as with many many posts here as have your posts no guarantee.
Also, Dr Liau probably submitted the article. But the NEJM author-center offers the option to assign co-authors to work on the article together and after. I think that is what happened here.
This is past absurd. If Dr B wants to read the NEJM online he would have to register his email account.
For transferring manuscripts:
If your manuscript is rejected for publication by NEJM and you elect to have NEJM transfer your manuscript to another listed journal, we will transfer your submitted manuscript and related files (including external peer reviewer comments for authors), your and your coauthors’ names and contact information, and a copy of the rejection letter you receive from us.
with his NWBO email thus under an NWBO account?
Could be to submit what?
There is of course no reason why Dr B would ever have registered with the NEJM in the past.
I suspect all three (Ashkin, LL, and Bosch) have an account and work on it simultaneously
I haven't gotten around that to do so, but here is the problem in that thesis. LL has submitted in NEJM before so that would not prove it's for the one we are all waiting for? with MB I don't have that problem