Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I believe the TLD presented is 4 years from last patient enrolled.
That would also explain the lower than expected actual alive patients at 5 years.
I am confident Avita would assist if necessary with treating US wildfire victims.
“Spray-on skin technology developed by Perth burns specialist Fiona Wood is being used to help hundreds of people who suffered horrific injuries in a Taiwanese water park explosion.
Perth regenerative medicine company Avita Medical has donated kits with the ReCell technology to help treat some of the teenagers and young adults injured at Formosa Fun Coast on the outskirts of Taipei on June 27.
The company said it had offered the kits as a humanitarian gesture, after reports of a shortage of cadaver skin to use for skin grafts.”
https://www.google.com.au/amp/s/thewest.com.au/news/perth-firm-aids-victims-of-water-park-explosion-ng-ya-125443.amp
“In 2002, 28 gravely injured victims of the terrorist bombs that exploded in the Bali tourist area of Kuta were air-lifted to Royal Perth Hospital. As head of the hospital's burns unit, Wood oversaw the emergency treatment, which included the use of the then experimental spray-on skin.”
https://www.healthcareit.com.au/article/australian-developed-spray-skin-burns-treatment-seeks-fda-approval
Umibe,
My DCVax-L survival estimates are as follows -
OS -> 1Yr, 2Yr, 3Yr, 4Yr, & 5Yr
91, 51, 32, 25, & 23
I based my control curve estimate on Rintega’s and Stupp’s Dose-Dense studies.
I suspect the actual DCVax-L control curve could thin out at the tail more than the above studies did because only NWBO tried to exclude long-term survivors (the pseudo progressors).
So I would not be surprised if my 5YrOS estimate of 23% ends up being on the low side when the unblinded data is released.
Thanks for sharing Lykiri!
Sounds like this Fractional Tumour Burden (FTB) imaging technology could be used to re-evaluate pseudo progression in our L trial.
Old MRI images can be loaded into the FTB software, as long as DSC data was collected, to produce the FTB images.
The very last question in the segment covers this.
He probably should have said the median of the top100 are living past 5 years.
I have estimated a blinded 5 year survival rate of 20% for this L trial which would mean around 66 patients living up to 5 years.
Hi Flipper!
Developing a soft touch in football/soccer is vitally important for the elite players. Social & amateurs can get away without this skill.
Getting players to focus on cushioning the ball as it arrives to them in simple kick to kick exercises can be an effective to improve this skill.
However I’m sure this MB is about sports drills even though people can be knowledgeable in multi fields.
Gary,
Agree, awaiting SAP acceptance could be a valid reason to remain blinded.
Given the time that’s expired since the SAP was rewritten I am hopeful it’s complete now and the decision to unblind has been made.
In that scenario we’d be waiting for the data to be scrubbed/completed.
GL.
Here’s a quick list of the pros & cons to unblind the trial now -
Personally I think it time to unblind.
Reasons to continue with blind
• Assure revenue from UK Specials Program (poor TLD could stop this revenue)
• Reduce the risk of insolvency from possible poor TLD
• Allow more time for better acceptance of more flexible FDA Approval Regulations
• Allow all trial patients to pass 5-year milestone from surgery and enrollment (note, Merke combo trial scheduled to run for 6 years)
• Increase TLD maturity for MGMT methylated subgroup (mOS likely > 38months)
• Increase pressure on FDA to intervene (look at TLD)
Reasons to unblind
• Bring treatment to patients earlier
• Recognize treatment revenue earlier
• Reduce capital raises at distressed prices
• Aid advancing this science by studying the unblinded data
• Move with new L & Direct trials
• Increase the prospects of partnerships or buyouts
• Recognize a potentially much higher share price
• After more than a decade it’s simply time
1, 3, 4, 6, & 15
Hi Senti!
My question-
Is there a limit to the number of patients that can treated on their UK Specials Program?
10, 18, 20, 9, 1, 7, 36, 19, 11, 28
April the 1st came early for next year!
Around March 2018?
Is your data from March2017?
What are 4Y and 5Y survival rates?
Tx vs control.
Thumbs up Jim!
Beartrap12,
The FOR vote was the catalyst for our price reversal, your post was its trigger.
NWBO now has the capacity and flexibility to raise the funds necessary to complete their L trial. Without this capacity our future would have been much riskier, maybe even forcing NWBO to unblind prematurely. So moving forward the last remaining obstacle that can cause our demise is poor trial data which is a good place for our investment to be at.
Our price leading to the vote fell some 50% from recent highs of $0.34 to $0.17. Perhaps the recline factored the impeding dilution from our share count increase and some financial risk from a possible AGAINST vote.
Now that the Vote risk is gone and dilution possibly already factored our price is reversing imo.
Almost all large shareholders I know did not trade their shares leading into the vote. I believe we have a strong retail investor base that will serve us well. With eventual positive results our price can rise quickly.
Novocure, with their GBM device treatment, enjoy a multi Billion market cap while we sit under $100M.
Once the markets recognise DCVax-L can provide similar or better efficacy to Novocure they will move us quickly towards a similar cap.
From my modeling work I am confident L can at least equal Novocure’s efficiency.
Thank-you Beartrap and all others for sharing your meeting notes.
It’s terrific to hear the voices of our management. It sounds to me like everyone is doing their best to do the right thing.
Good Luck everyone!
& thank-you abeta for your contributions!
Flipper44, thx for clarifying before I got a chance.
RKmatters, thx for contributing the extra UCLA study info.
I ran my model using UCLA's curve as the control arm and got the following result. This scenario would be close to our worst case imo.
Tx comes out with a 3 month benefit over control, 23 vs 20 months.
Thanks for pointing out the reason for that discrepancy to be honest I wasn't sure of the reason but chose to use the higher numbers.
These are results from my latest OS modelling. Originally I thought the Control arm would track closely with Stupp's MGMT unmethylated KM curve but since ASCO I think that's too bullish.
MB's 90% of patients received tx comment would mean ~12 control patients have PFS evented since Dec'16. Using that assumption my modelling says NWBO's control arm has to be slightly stronger than Stupp's all patients KM curve.
So my Control arm curve starts off slightly stronger than Stupp's all patients but then towards the tail end weakens and approaches Stupp's MGMT unmethylated curve since psPD patients are mainly removed.
Cross-over effect on Control arm is a wild card but I am not expecting it to be substantial.
a more detailed description at my blog
Flipper44 & RKmatters,
I recognize there are many differences between Stupp's and NWBO's patient populations both on the plus and minus sides of affecting survival.
Given all the differences I still think using Stupp's curve as an estimate for NWBO's control arm is far better than using UCLA's curve.
UCLA's survival curve looks too strong in fact it tracks loosely with Stupp's MGMT methylated patients which is the best GBM survivors sub-group. This sub-group includes the longest-living psPD patients which should not make it into NWBO's trial.
Here's a survival competitor chart I put together for reference -
Stupp DD - all patients Survival Data
Proportion Survival
Surviving Time
1.00 0
0.95 3
0.90 4
0.85 6
0.80 8
0.75 9
0.70 11
0.65 12
0.60 13
0.55 16
0.50 17
0.45 18
0.40 21
0.35 23
0.30 27
0.25 31
0.20 36
0.15 44
0.10 51
0.05 60
Hi Leprecon7777!
Thanks for your interest in running our trial OS analysis.
May I also suggest you consider Stupp's Dose-Dense study for your SOC curve.
https://www.ncbi.nlm.nih.gov/pubmed/24101040
We should get data updates at 2016 ASH, early December. GL
Hi Flipper44!
I sent Grant a tweet asking him to clarify.
I am now assumed we are nearing the 248 events which the latest PR is suggesting.
If we had not reached the 1st IA by 2016 then L is a winner by my modelling.
Grant's mid-2016 IA date may be a typo. It makes better sense if his IA prediction was mid-2015.
Hi Turtle65,
I was paraphrasing Grant Zhang. He says L will be approved in 2018 (50% chance).
My L estimates are more optimistic, hopefully we wont have to wait too much longer to get L updates.
"DCVax-L FDA approval in 2018" from memory
So then your investor activism stops at posting on message boards?
Don't expect to be taken seriously if that's the case.
I actually lived by the UM stadium and went to watch several football matches, great atmosphere.
I also liked going downtown during matches.. it was very empty, no waiting for service and very easy finding parking.
Thanks for the links Maverick_1. They are helpful.
Your background and experience in the financial industry is far more extensive than mine. My interest in investing and money management began a little over 15 years ago when I lived in Ann Arbor Michigan. I quickly migrated to the medical stocks universe because of my interest in science and medicine. I used Marketocracy.com's money management simulator to develop my stock picking and portfolio management skills. After about a decade of toiling at Marketocracy and eventually out-ranking their other portfolios they invited me to manage client funds which I now do through SMAs.
However I am a Manufacturing Engineer by background, I've worked in the Automotive industry for over two decades on two different continents. I have worked at several OEMs and suppliers performing a variety of roles in product design & development, testing, manufacturing, product launch, plant equipment & machines, research and marketing.
I have also done post-graduate studies in finance and am a qualified but not practicing financial planner.
That's a short bio about me :)
Northwest Biotherapeutics continued to decline during the period as sentiment towards the company remained weak in the absence of any news. We feel we have acted appropriately in raising governance issues at the company and continue to wait for it to inform its shareholders of its actions and developments in due course.
https://woodfordfunds.com/insight/wpct-interim-results-2016/
This is an extract from Woodford's latest post.
He is holding and waiting for news like many of us.
AVII7,
I disagree with your assertion that NWBO's study data is completely corrupt. Their study data has been put together by professionals in medical researcher and science. Professional folks rarely partake in fraudulent conduct, at this point I will accept the study data as presented.
Hi Chris!
Great to have your support here. I am looking forward to reading your article and wish you all longs luck.
I actually live in Australia but I consider myself a little American too since I also lived on your continent about a decade ago.
Hi John!
I am planning to pen something about NWBO for my blog hopefully soon. I have been waiting for a substantial news release from the company to base my article on. I try avoid speculating too much.
Also thanks for your NWBO i-hub twitter highlights packages. Helps me follow the conversations.