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I think this line from the PR is interesting;
"We believe DCVax-L can offer a much needed new treatment option for GBM patients, both alone and in combination with other treatment agents."
IMO this suggests that in addition to the P3 trial results the MAA includes other data/results. I doubt this surprises anyone but I am surprised they appear to be seeking approval without requiring current SOC as part of DCVAX treatment. I think this is good for patients and investors.
I'll guess $11
But remember in the end the sloth did have the pedal to the metal.
Flipper,
I suspect the data presented to the RA's will have many graphs with many lines, there could possibly be several types of control presented to help make the case for efficacy.
Thanks Dr. Bala.
I thought slide 18 was interesting that it showed the control arm consists of External data adjustment + partial control to comprise the control arm. I suspect this is relevant to the PIII trial.
Apologies if someone has already posted this observation.
IMO, LP will use the journal article as a sales brochure.
She will shop NWBO and hope for interest from multiple bidders.
On 11/16 he posted on IV.
Wonder why he quit posting here, he was one of my favorites.
Thx Senti.
I'm lazy, I copy/pasted.
Manufacturing at Sawston may make the politics of approval and pricing a little easier in the UK/EU.
Speaking of looking under the hood, is there any chance that MRK has seen preliminary data from the rGBM combo trial?
I think the clown seated at the bar is Russ T Nailz, I can't believe he has not been picked up by a national news channel.
My wife says I'm more idiot than savant, she is probably right....
.28
.82
The full 2:1 set (actually 70/30).
While I think we have a winner I do suspect the control arm did better than the 5% historic SOC.
Assume control did 10% and treatment did 20%, do we still have a winner?
Also assume there is additional analysis that shows if pseudo, etc are accounted for the separation is wider.
That is what I was trying to say.
Duffy was easily in the top 10% of the employee population, not mid-level.
Ex,
This is the third time you've stated this;
"Are you talking about Duffy? He was a mid level employee"
Let me add clarity.
The vast majority of the corporate employee population are individual contributors, supervisors and managers. They are responsible for the daily execution of the business.
The vast minority of the employee population are directors, VP's, presidents and officers. They are responsible for strategy and direction.
While Duffy may not be the executive whale that some imply he is still a very nice catch for little NWBO - far from a "mid level employee".
Was the trial protocol much different for determining progression than how non-trial SOC is normally determined?
If the control arm was at a disadvantage compared to non-trial SOC the FDA may have stepped in.
This may also explain the lack of second surgeries.
Wouldn’t this make the comparisons between the Optune and DCVAX trials even more favorable to DCVAX?
Does this mean the 2 month offset can be removed when comparing the 2 trials?
“Didn't the optune study remove true rapid progressors but keep pseudos, so a comparison between GTR for both studies should be close. I know you've mentioned they have 5% less mgmt+ or close to that. Then standardizing the mOS from randomization (instead of from surgery) for dcvax trial. Looks good to me? What criticisms to this do you have?”
Bigger cracks me up;
edit - looks like he deleted his Ron Jeremy remark.
@biggercapital
2m2 minutes ago
More
A tail so thick, Ron Jeremy is ashamed.
@biggercapital
10m10 minutes ago
More
Drum Roll! n=100 mOS 40.5 months in 2017, expanded to 58 months in 2018 Interim Data analysis (top 100 survivors). Houston We Have A Tail! #GBM $NWBO
I think you mean "dry" powder - white powder is completely different....
"My only concern is I don't have enough white powder"
Someday everyone will be judged according to their deeds.
Surprised you're from the South, I would have guessed NJ.
Personalized DC vaccine for ovarian cancer.
Small trial but DC vaccines are getting more press.
www.cnn.com/2018/04/11/health/ovarian-cancer-vaccine-study/index.html
AVII, I should have used a period rather than a comma. I didn’t mean to imply you stated anything but the patent assignee.
In my opinion there is something interesting with the relationship between NWBO, Four M and Sawston. My speculation that the patents may also be connected maybe completely off base but not outside the realm of possibility.
If patents were reassigned to NWBO that would be a good thing, even if there was some type of compensation to Four M.
I don’t understand why others thought I was being negative.
Wow kab, I didn’t realize this was your own personal MB and that I need your permission to offer an opinion.
The appraisal was big enough deal for LP to file an 8k.
Nowhere did I suggest there would be any BO prior to results.
I suspect LP is getting all NWBO affairs in order.
I think there is a chance AVII is correct concerning the patents.
We’re all entitled to our opinions.
Per AVII Four M is the assignee of the patents, NWBO needs to possess the patents to be sold.
I speculate we’ll see some type of deal with Four M for the patents.
Now that would have been bullish if LP would have used that $4M to convert warrants into common.
I suspect once the trial is unblinded we’ll be stuck submitting those results. IMO huge mOS and probably failed primary PFS, heck the control pseudo progression could be very long lived and negatively impact OS separation. Of course the bears would say the results were due to selection bias.
I think they’re staying blinded until alternate AA is approved, or in process.
This will give us 2 shots on goal for approval.
How is LP supposed to communicate that she is concerned the trial may fail and alternate AA is the plan? It probably wouldn’t be well received.
I do suspect something big is in the works, just need to see how big.
Obviously all speculation on my part, hopefully imminent is soon :)
All good points and I agree with you.
I still have trouble with the premium a BO would take.
Several things point to BO but seems early - hard to believe any BP could pay xBillion for a company with a $121M MC - unless there was some really compelling results.
I wonder if anything has started at Johannes Gutenberg University Mainz in Germany with the Keytruda/DCVAX colon combo that gave Merck a look under the hood....
Thanks Whitewater.
How many colleagues normally attend these type conferences?
"I can confirm that Lindas presentation is taking place at 10am on the 23rd January during our morning plenary discussion.
Linda is registered for the event and she will be attending with 4 of her colleagues. "
Interesting article on CNN;
http://www.cnn.com/2017/12/13/politics/joe-biden-consoles-meghan-mccain-cancer/index.html
Biden cited ongoing research and work on glioblastoma, encouraging McCain to remain hopeful.
"There's breakthroughs that are occurring now, there's four things that are going on, and it can happen tomorrow," he said. "You gotta maintain hope. There's hope. Hope -- you have to have hope," Biden said.
"I swear, guys, we are gonna beat this damn disease, we really are," he added.
Thanks Ex.
I doubt the share count/shelf thing really matters anyway, they are going to have to pull a rabbit from the hat or at least a dove from the hanky before the ASM.
I know you’ve stated that you don’t expect results anytime soon but I think they need to show something regarding P3 success to stay afloat.
BTW – I’ve accumulated a few shares over the last 9 months so my PPS is very low and this is a tiny portion of my portfolio but I would really like to see this help those affected by this terrible disease. I do believe there is efficacy but we’ll see if it is enough to overcome the potential obstacles - false progression, cross-over, etc.
Some previous posts had indicated that the shelf itself was the limiting factor in raising funds and that it could not be easily changed.
If the only real limitation is authorized share count I suspect the company would be able to get the necessary votes to increase the 450M cap.
Maybe they need the cash for data lock and analysis.
How much does that cost?
What happens if the DMC identifies false progressions while analyzing the PFS data?
Let's say 20 treatment patients were wrongly identified as progression when they weren't, will they delete them from the PFS calculations?
Could this be why they continue to collect PFS events?
Thanks,
Bum