Not sure what we are waiting for...They should have 233 OS events by now, it is very unlikely that they are struck at 231 evens since May/June time frame. No update what so ever....hoping for late breaking abstract for ESMO17 (but you never know with this management...we may not have data for another 1 year or so). Someone always knows something....It looks like market and leaks point towards failure.

Is there any update from today presentation ?

I searched all ESMO abstracts, They are not presenting anything unless late breaking abstracts which will be released on first day of conference.

Thats what I am also thinking...Might have failed primary endpoint and trying to get OS data. One thing I wonder....Dont they need to reveal that information under SEC rules ?

What NWBO is very unusual and not a common practice. Generally once we have data for primary endpoint for pivotal trials company release data and wait for secondary endpoints (OS) to mature. I dont think NWBO as PFS and OS As co primary endpoints..PFS is primary endpoint and OS is secondary endpoint.

Are we still waiting for those last 2 OS events to occur for P3 readout ? OS events will occur gradually, suddenly they dont stop for 2 months and then kick in...It doesnt pass the smell test.

mPFS of placebo arm in this trial will be higher than SOC mainly bcz NWBO is recruiting slightly healthier population than historically while elimination rapidly progressing patients from the trail and also surgically removing patient tumors.

You mean something crooked...yes you can count on them.

How do they compare OS data ? DCVax-L arm against Placebo arm (10% didnt receive DCvax-L) or placebo arm that include crossover patients those received DCVax-L at some point during the trail ?

How do they compare different arms when you have cross over ? Do they present Placebo Vs Crossover Vs Treatment arm ?

They could have presented unblinded data if it looks promising like they did for OS data

Not a single word on PFS....why ?

My take is they failed primary endpoint (PFS) but still there is hope in OS data (secondary) and thats what matter for this trial.

Why didn't they talk about PFS ?

Let me try with some hypothetical scenario where 167-331 patients do lot better than 1-166 patients.

Consider 166th patient died at 25th month after randomization and 1-165 OS is less than 25 Months. 167-331 let say they all lived for example

1) lived for 26 months and above

2) lived for 40 months and above

3) lived for 60 months and above

In all three cases above median OS of the trial will remain 25 months and it doesn't change, but If some of the 167-331 patients die before 25 months then mOS will be less than 25 months 165 patient become 166th .

Note: numbering for patient is based on OS but not actual recruitment number

I think you are wrong here....If we already know 166th Patient OS data then median Overall survival (mOS often referred) data will not change even if the remaining patients cured (live another 10-20 years). But mean Overall survival will change as it is the average OS data of 331 patients. Median is different from mean. Median OS data will be when 166 patients in trail died. It (mOS) can get worse with remaining patients low OS data but not better.

This Management madness need to stop...It isn't helping anyone other than shorts. Market is assuming NWBO P3 trial is total failure and management actions doesnt help...

Can you point out one example where FDA granted AA without interim or full data readout of the trial ?

The point I was making reference to other poster that they could announce PFS and OS data results separately, primary endpoint outcome dont need to wait for maturation of secondary endpoints....some I have a feeling that Management is hiding something here...waiting this long for primary endpoint outcome after 248 events occurred doesnt pass the smell test. By the way you have to stupid and crazy to short at these price levels....

So you never seen a trial that failed / met primary end point (PFS) and waited long time for maturation of OS data (secondary endpoints). Look deeper...there were quite few examples in past...here is one such example.

http://investor.celsion.com/releasedetail.cfm?releaseid=737033

While we wait for OS data Why not release PFS data (primary endpoint) ? If They met primary endpoint they would do it before this raise....I think it seems more clear that they failed to meet primary endpoint and waiting on secondary endpoints (OS), to get something out of this trial. This is only logical explanation....everything else is pump and spinning it to be positive.

excellent prediction.....Dont forget your past list as well. Keep it up good work.

what happened to this ?

https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/proposed-technology-appraisals#DCVax-L

Does this loan/debt mean no dilution before results ?

Why does it take this long to asses primary endpoint point (PFS) ? They should have already that data and complete analysis within couple of weeks after 248 events. Why do they have to back and visit every site to analyze PFS data ? Something stinks here...I haven't heard this before (reanalysis of PFS). Any known examples of such things ?


They are contradicting their own statements. The company says the study has accumulated a sufficient number of events (248) for the progression-free survival (PFS) endpoint. Generally statistical analysis will take less than 2 weeks.

What happened to this decision today ?

https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/proposed-technology-appraisals#DCVax-L

Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators

26 January – 23 February 2017

What is current $NWBO cash position ? Last time they raised $10M in Dec 2016, how long does that last ?

$TCON failed GBM trial

http://ir.traconpharma.com/phoenix.zhtml?c=253885&p=irol-newsArticle&ID=2244945

I use this website for calculations

https://www.medcalc.org/calc/comparison_of_proportions.php

Simple and crude math...

14% of 331 received SOC, i.e 46 patients. Let say 44 patient died and 2 patient will live and dont die ( atleast until 231 OS events).

195 patients of remaining 285 will die to reach 231 OS events i.e 68%, even if all 231 patients had very similar OS data that will be still statistically significant for patients treated with DCVAX-L

Results

Difference 63.5 %
95% CI 51.4727 to 70.1557
Chi-squared 65.909
DF 1
Significance level P < 0.0001



Lets compare total control arm vs drug arm

Control arm: 110 patients ( 44 of 46 die with SOC + 66% of 64 with DCVAX-l die, i.e 42), so 86 patients of total 110 in control arm will die, i.e 78%

Drug arm : 221 patients ( 145 patients will die i.e 231-86), so 145 of total 221 patients will die to complete 231 events, 65%. Lets assume for simple calculation all patients died had almost same OS data.

Results

Difference 13 %
95% CI 2.1093 to 22.9258
Chi-squared 5.819
DF 1
Significance level P = 0.0159


This is very crude analysis. Still DCVAX-L wins innOS data

reasonable....It is more likely that DMC already communicated with FDA and FDA convinced to remove clinical hold. Atleast DMC should have seen a trend in OS data.

Anyone know the current cash position ? Also how long do we last with current burn rate ? If will be nice to have for them until end of summer.

So Does that mean, soon they could announce statistical significance on PFS ?

"In this process, all data from all of the treatment visits and follow up visits for all 331 patients in the Trial, must be subjected to quality control checking. The process involves in-person monitoring visits to all of the 80-plus sites in four countries to review the files onsite, as well as other documentary confirmation and checking of all MRI images. As such, it is a multi-month process. While this process is under way, OS and PFS events will continue to accumulate".

I get impression from this paragraph even PFS will take few months.

Still dont understand why do they need few months for primary endpoint (PFS) ? Generally they dont go back start PFS analysis again from Patient 1, mostly they have all that information except last few patients. In principle it shouldnt take more than 2-3 weeks to complete statistical analysis for primary endpoint.

quick question to board....

Here is approval of abiraterone for prostate cancer (Mar 2016)

http://www.fiercepharma.com/pharma/men-england-to-finally-have-routine-access-to-uk-discovered-prostate-cancer-medicine-zytiga

After approval NICE had Proposed technology appraisals in (Oct 2016)

To appraise the clinical and cost effectiveness of abiraterone within its marketing authorisation for treating newly diagnosed metastatic hormone-naive prostate cancer.

https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/proposed-technology-appraisals#abiraterone

How come DCVAX-L is having having Proposed technology appraisals before approval ?

Once you have 248 events (Progression or death) then it should take less than 2 weeks to report statistical outcome. If they are taking longer than 2 weeks then it's usually bad news due to data miming and trying to find artificial subgroup to show statistical significance. At the moment no one knows WTF is going on.....BTD/AA simply pure BS without any substance.

apparently its not one week yet in NWBO calendar year...If you are not following your own timeline what is the point of this and previous PR ?

https://www.sec.gov/Archives/edgar/data/1072379/000114420417003329/v457335_ex99-1.htm

May be they haven't yet recovered from flu...

Thanks for your reply. so they will be comparing KM OS curves for control arm (110 patients) Vs treatment arm (221 patients), did I get that right ?

How do they compare mOS ? Is it control arm (include crossover patients) Vs treatment arm ? Or is control arm (exclude crossover patients to receive DCVAX) Vs Crossover patients that received DCVAX Vs Treatment arm ? There might not be statistically significant difference between crossover patients that received DCVAX Vs those received in treatment arm. Or Do they compare all patients that received DCVAX against historical control (which may not be very convincing might attract lot of short articles).

yes, What are the odd of company releasing pivotal data at conferences/meetings without pre-announcement ? I could be wrong, but Anyone site one example of such instance ?