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Thanks! I stand corrected, NWBO does have a "presentation" at ASCO.
I can't find any information on this session on the ASCO website. Can you point me in the right direction or tell me how you found it?
"Ready was simply wrong that this view has changed. Instead, it was reaffirmed 5 days ago."
So, basically you're saying that regurgitation of the same PP presentations and promises of "phase 2 trials in parallel" at every investment conference since the December 2014 Oppenheimer’s conference is confirmation that everything is on track?
I don't think they submitted an abstract, or plan to present at ASCO, other than their regular booth. Hope I'm completely wrong and that Linda has a big surprise for all of us.
Last year Linda promised us she would shout the good news about Direct from the rooftops. I think she has made good on that promise and we continue to hear about 4 specific case studies over and over. Early on, there was mention of more "responses" but there hasn't been any further mention of the others and it leaves me wondering if maybe we did jump the gun and declare success a little prematurely. Either they are keeping a very tight lid on super results in an unblinded trial, or they are being completely transparent and reporting the few successes they are seeing. I choose to believe it's the latter.
LP sometimes provides hints. For example she hinted several times about the L trial enlargement (with copious amounts of positive spin) before it was officially announced.
In the 10k the tone with regard to Direct seems to have changed. My guess is that the results are not nearly as positive as they had hoped for and we are starting to see a shift from certain plans for "multiple phase 2 trials running in parallel" to "possible" phase 2 trials. This also provides a little legal protection since they have notified the public it is now less likely than was expressed in several statements at multiple investor conferences over the past year.
4 out of 40 partial responses isn't anywhere close to the response rate seen in the pre-clincial mice studies. In light of this, it is logical they would pursue combo options with CI's (which LP has also hinted at), but it doesn't appear they have been able to find a willing partner.
Thus the recent effort to shift the focus back to L, adding more sites, etc.
Interesting take. Since you believe L will swamp Novocure's results by such a large margin, and we already know LP wants to see the L trial all the way through, when can we expect the trial to reach the final data collection? Assuming enrollment can be completed in the next 1-2 years (might be pushing it), I imagine we may be looking a few years down the road if the treatment is as effective as you believe. The longer the better I suppose.. (proof that it is very effective)
You're certainly entitled to your opinion/speculation, but I'm not exactly sure what your point is. Novocure will have their phase 3 trial data before the FDA for review long before NWBO's trial ever reaches completion. Are you saying the FDA will postpone a decision regarding Novocure's treatment indefinitely until the L trial is completed?
It appears there is some evidence from the Novocure EF14 randomized phase III trial that PFS under SOC is around 4 months. So DCVAX L would need a 100% PFS increase to reach significance (8 months vs 4 months if a similar PFS is found in their placebo group). Is this correct?
I also find it interesting that Novocure was able to enroll 700 patients for their phase 3 GBM trial from 2009 to 2014 as compared to NWBO.
Also, are there any negative consequences to DCVAX L if Novocure's treatment becomes the new SOC during the clinical trial? How would the FDA account for an improved SOC when reviewing NWBO's L trial data?
Great! Sounds like smooth sailing to the finish line. Of course we all hope it takes many years to reach the interim and primary endpoints of this trial (for the patients sake).
Guess I'm still a little confused on how the determination is made that they are Pseudo and therefore excluded. Since they are still enrolling, isn't it possible more than 32 will turn up?
Quick question for the board. In one of the 2015 ASCO abstracts (e13055) the study includes results for GBM patients with pseudoprogression and indicates that 35% of the pseudo group had a median survival of 34.7 months. If there is a close correlation of PFS and OS typically seen in GBM, is this cause for concern in the DCVAX L trial? If the placebo group in the L trial ends up with a high percentage of psuedos, is it possible we may see a very high PFS threshold that the treatment group will have to exceed by 4 + months to reach the desired p value?
Although DCVAX may soon be considered horse and buggy technology, NWBO is one of several companies that helped pioneer the DC vaccine approach over the last decade. Regardless of the outcome, these clinical trials will provide very meaningful scientific research and data that will help future scientists and biotechs develop much more effective treatment options in the fight against cancer. LP, NWBO employees, and investors should take a lot of pride in the sacrifices they have made to further this research. It is very possible we will see major breakthroughs in cancer treatment in the next couple of decades.
One last thought from an investment perspective. Since most small biotechs eventually fail, it is prudent to invest accordingly. Woodford has set a good example with his portfolio allocation of less than 1% to NWBO. If things go south, the damage to the portfolio will be minimal. This is a responsible approach that should not be ignored.
Maybe so, but don't you think there is extensive consulting with the oncology departments, surgeons, etc., when a new site is prepped for participation?
If it were me, I would encourage patients with this horrible disease to enroll in the trial. My site would be enrolled as quickly as possible. I wouldn't have to disclose my personal "speculation" to patients, but I would make sure they knew of the trial. I'm not sure this is happening, hence the long delay in finishing enrollment.
Common sense certainly isn't very common anymore.
Let's pretend I'm the principle investigator at one of the trial sites. The strangest thing is happening. 2/3's of all my GBM patients in the DCVAX trial are living years longer than is typical. I just can't put my finger on what is happening. Darn these double blind studies that totally keep me in the dark.
Now, what part of that don't you understand?
Sounds like the shorts have been exercising some of those warrants they received during the more unfavorable financing days to keep a lid on the price. It is probably their last line of defense and final avenue to find shares to sell. Woodford will put the hurt to them soon enough and they will have no choice but to cover at much higher prices.
The longer NWBO drags its feet on the possible phase 2, the more likely another company will reach the finish line first. And why is financing still a going concern? They have money in the bank and one of the biggest investors on the planet backing them. Money isn't the problem, something else is going on.
If patients and doctors were seeing such results, don't you think enrollment would be completed by now?
Anyone excited to see the ASCO abstracts? Wish NWBO had something to showcase.
Nope, just hoping to sell you some puts like last time. Rinse and repeat is my MO.
Still waiting for the downward pps pressure.
Yes, it was supposed to by announced last Fall. Just speculation on my part, do you think the delay has anything to do with establishing agreements with other centers to conduct the phase 2? It seems Linda alluded to other locations at one of the investor conferences.
Flipper44, when do you expect the Direct phase 2 treatment indications and parameters to be finalized?
Oh okay, now I get it. So the COGS from Cognate should be greatly reduced since they don't have to pay for the infrastructure, lab, equipment, etc. I'm sure it will all be above board. Any idea why the terms of the agreements between nwbo and Cognate are all restricted from public scrutiny? I'm sure it's in our best interest to be kept in the dark..
Prayer has also worked for some. Yes, miracles do happen.
Even some of the fellow longs on the board, that are a little more savvy on the technical side, couldn't find the cup and handle that flipper first tried to identify. Sorry, I think your strengths are in other areas, like designing magazine covers :)
I'm not familiar with the cup and saucer pattern, but I'm sure it's great when serving tea.
Is it true that we (NWBO) are footing the bill for the UK facility that will be operated by Cognate?
So you think DCVAX L is a cure for GBM?
It is very possible that NWBO will see a similar reaction as NLNK encountered today with a continuation at the 1st interim.
Investors will see it for what it really is (further delay, further dilution, etc.). Thus the recent attempts here to spin it as a "positive" event.
I clearly remember all of the 1st interim projections made by the diehards last year and the claims that it would be foolish to be on the sidelines..blah blah blah. What a bunch of baloney! I'm sure we'll see more of the same in the coming months.
Well he certainly has another chance to buy at 7.40 and lower. I think we are on the edge of a major correction.
He nailed it when he said "The fact that Linda refutes my argument by citing the 2013 Cell paper by the TCGA Research Network and their 21,540 figure indicates that either 1) she misunderstood my argument or 2) she is presenting a straw man argument to avoid addressing the real issue."
Note, this isn't the first time we've seen straw man arguments to avoid discussing the real issues.
What I found the most interesting, was the exchange between someone with a close personal experience with DCVAX in a fight against cancer and the author:
" My sincere apologies Mark. As we've been able to speak offline I've gotten a chance to understand your viewpoints and the opportunity to present the data that you've accumulated in your own research to share with others. I hope in the future I will be more open to welcoming opposing views as iron certainly sharpens iron. The more we learn, the more we realize how much we don't know.
Best wishes to you."
Ben demonstrates integrity and a very open minded approach that we should all try to emulate. Of course some here would rather try to discredit anyone with personal attacks if/when their statements don't fit an eternally bullish perspective of NWBO and all things related. Okay, head back in the sand. Carry on..
I found Kroenke's article on NWBO extremely interesting. It was nice to read a legitimate scientific opinion of the DCVAX technology.
I also found the comments from B. Hodges interesting (I wonder what info they exchanged that completely changed Hodge's opinion of Kroenke?) and the follow up article http://1.usa.gov/1ElD8eZ. Very useful information.
No, there's really no need for me to do that. Instead, I'll just jump up and down with my pom poms and speculate that this must be a positive indicator for nwbo. The details are not relevant to my optimism.
What near term catalysts do you foresee, RK? I don't have much on my radar? I do think the biotech and larger market correction have just begun.
That makes sense RK and you certainly aren't alone in your approach. Just curious, do you ever read any of the material you so generously go around and post to various sites, or do you just assume it's credible?
NWBO will cure all cancer. What else do you need to know?
It is all speculation. So please stop trying to spin everything in a positive direction when we simply do not know.
"The least of which might be patient death"
What makes this possibility the least likely? Are these patients not on death's doorstep? Come on, flip.