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Wow! Now that’s certainly interesting. I’d like to know the details of what they are doing!
Would be nice to hear anything at this point
Sp that is. Damn autocorrect.
I do not believe the efficient market theory
So doesn’t predict squat.
Gotta be getting close
The Company is progressing through each of the stages of work needed to reach unblinding of the Phase III trial for Glioblastoma, in accordance with the roadmap provided by the Company in its November 19, 2018announcement following the Society for Neuro-Oncology meeting.
After 5 months of work with independent statisticians, the draft Statistical Analysis Plan (SAP) is nearly complete at this point. (The SAP contains all of the planned analyses for the data that will emerge from the Phase III trial.) This has been the most labor intensive stage for the Company on the road to unblinding of the Phase III trial data.
To save time to the finish line, the independent CRO that manages the Phase III trial has been checking and validating all of the trial data, in parallel with the Company’s work on the SAP. This involves checking all of the data points in hundreds of pages of case report forms for each of the 331 patients. The process has generated thousands of “queries” relating to any missing data or data questions, as is typical in a large trial. This task is also nearly complete, too, with only a few hundred queries remaining to be resolved.
As soon as the SAP is finished (including review by advisers), it will be submitted to the regulatory agencies for each of the 4 countries where the trial was conducted, for their comment and buy-in. As soon as the SAP process is completed with the 4 regulatory agencies, and the simultaneous data checking is finished, the trial will be unblinded and the data analysis stage will take place and result in top line data.
Just to point out that the timeline is a fluid expectation. Meanwhile the data continues to collect
Gotta be getting close.
“Until we reach data lock, the data will continue to mature. As we have cautioned before, the data may get either better or worse as they further mature. Also, the interim data are blinded aggregate data, and we do not know the breakdown between the treatment arm and the control arm of the trial.”
Ms. Powers continued: “We believe it is now appropriate for the Company to move forward with the several stages of work that are needed to reach completion of this trial program, despite the fact that there are good arguments for allowing the data to mature even further. The upcoming stages include finalizing the Statistical Analysis Plan, conducting the final data collection, data validation and data lock, and then unblinding and analyzing the data.
“Each of these are multi-month processes, and will involve tremendous work by both our team and teams of outside experts. In addition, virtually all aspects of the Company’s work involve pioneering. There is no well established pathway, and any projections or predictions are subject to material changes as we go along.”
And this too:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3071163/
I wonder if they will incorporate these findings in the trial results
An interesting read from Dr Prins:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4873445/
You are correct. The gold standard
Interesting. Data up to 49 months for this trial
Yes it is interesting the games they play. This is why it is sooo important for everyone to do their own research.
Newbies should really stay away from biotechs until they get some experience
Oh yes and pyrr was short AMRN tooo.
Whoops!
Lol. Their twitter feed is a non stop tail against AMRN.
Nothing new to see here.
Located in a nice part of Florida though
Ya this new “research” website. Has only one report on AMRN and looks very biased to the bearish side.
It strangely sounds exactly like Adams poly sci talking points
Hummmmmm
Sorry pal. Gotta do the work yourself
You should also follow the thread and read the responses of Carlo Rago
Already been dealt with.
We are already informed of a fat long survival tail in the interim results
So the SEC was involved with creating fake news.
Not surprised
Nothingburger.
Gotta get the home run before anybody gets treated
And how many people are still alive after all these years?
http://newsroom.ucla.edu/releases/personalized-vaccine-increase-long-term-survival-glioblastoma
Just chilling until news!
And November???
So you are expecting absolutely no new this month eh??
Trivax:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3446251/
Nothing like dvax. I’m not surprised to see such FUD
They will announce real world results. Not mathematical wizardry.
I’m in no hurry to get exact results. Assures us of approval and possibly standard of care status!!
Winning!!
Results will be announced when ready.
Could be tomorrow, Monday, next week, next month, whatever it is is.
Getting real world results takes time!
Think standard of care! How many still alive after all these years??
https://www.scribd.com/document/411229128/A-Dendritic-Cell-Cancer-Vaccine-Shines-Brighter-for-Glioblastoma-Patients
https://smithonstocks.com/northwest-biotherapeutics-managements-decision-to-determine-survival-tail-for-dcvax-l-in-phase-3-trial-in-newly-diagnosed-glioblastoma-was-absolutely-the-right-move-nwbo-buy-0-25/
Les mentioned in the interview that the L trial is “VERY near the end”!!!
It is a curious thing that they pulled the video off the web site. Maybe too close to major news???
Yes but Les cannot control the words and actions of the host.
Why not get the word out???
I’ve seen CEO’s give interviews days before results, many times.
Very common actually
He did mention that the L trial is “very near the end”
They asked him to do it.
Why not??
It wasn’t unprofessional of Les, it is like the host isn’t taking this subject very seriously.
Is the moderator a comedian???
They do not have any fees or restrictions that I know of. If you are buying you need to have the cash in the accounts for a certain numbers of days so the check clears. Wires are ok. Can’t margin otc.
I can buy or sell at will. They probably get a piece of the spread between bid/ask. Schwab is not a market maker of nwbo