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I would put the overvalue of my holiday home in NWBO shares and double my already substantial holding in NWBO but I won't. The reason is not that I think that data is bad, I believe its overwhelmingly great. The reason is because of NWBO's silence and its refusal to update shareholders. This is the only biotech in the history of biotechs where the market is fairly certain that data is great but it is not certain management is capable to produce TLD and a journal publication ever, for whatever reason. If the market was convinced we would see topline and journal publication very soon we sit above $2.5 and stay there.
Perhaps after journal publication, the market similar not certain NWBO is capable of submitting a BLA?
Progressed… not died.
thanks
aah if senti meant pseudoprogression in the treatment arm, which is the healing process, and is exactly what happened, then in there lies the confusion. But with eventing usually is meant dying and not pseudoprogression, so its good to clear up the confusion.
IMO, it was done to sort out what was happening with the treatment arm, and that the DMC may have seen these patients were eventing more rapidly and earlier than anticipated, and then their counterparts in the control arm.
ha, thanks for the entertainment advice I will add this advice to my new novel "Waiting for Northwest".
My publisher Toucan Publishers told me my novel will appear in the coming months. So really excited about that.
men, you make me want to go to youtube and relive my childhood with BB
yes its absurd
you are both immensely appreciated here
judge predicted the downtrend just before it began end Nov with a huge reversal hammer
If I knew that all I had to say is what I said to make him leave I would have said that much sooner lol
$20? sold now lol me too!
I think differently but the whole discussion is not so much of interest for I, like Poorman, predict NWBO will be bought soon after TLD+publication.
I personally think NWBO will be bought for 24 billion max = $ 16 per share fully diluted
Under promise over deliver.
- 1 magnitude = 10X
- For example purposes, let's assume "several magnitudes" means 30X
DCVax-Direct valuation of $150 to $300B or more.
yes his valuation prediction is absurd low. I have been conservative about NWBO's valuation and had good laughs about $ 100 per share or more EOY but SOS's is ridiculous.
Previously in one of his blogs, he predicted $ 8 billion right after topline data and now it's in coming years. Alo when comparing Novocure, never mind the corrupt data, after Novocure published its data the MC jumped to $5 billion, so why should NWBO be any lower?
This study basically comes to the conclusion that it takes ~300 days from when the company sees the data to the publication date. I don't think we know when NWBO actually has seen the full data. Scotty always points back to data lock and starts his timeline there. This study makes sure to point out that the correct measurement is taken from when the company actually sees the full data set.
Ok clear
Well I'm glad you know that you can't do an IA without an SAP. I didn't, and still don't know that. What I do know is that there was not a previous SAP for this trial, and that the protocol for this trial states that the interim analysis is done WITH using the SAP.
Aah ok then that is cleared up thanks
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.