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Any idea what current standard of care for GBM costs insurance companies? Thanks
Prior to the screening halt events, when you owned the stock, you held management's competence in very low regard. It doesn't sound like you consider the screening halt in and of itself to greatly increase the risk of failure, so what changed?
In the big picture, will the recent events have any impact on the eventual SP we will see with unfavorable trial results? What about the SP we will see with AA designation? How does the screening halt factor into either of those scenarios?
Really? You had reasons to own this at much higher prices did you not? The primary of which was the reward part of the equation I imagine. Well, the potential reward is still flying high in the stratosphere and the opportunity costs you less today (what you have to risk for the same reward). The probability of success/failure is unchanged from a couple of months ago IMO. Do you think the risk has increased?
Hey Stepp. 5's are very possible with the current bio sentiment. I wish I had followed my instinct and sold this in the double digits waiting to repurchase closer to current levels. You have to admit, this is one of the most attractive entry points we have seen all year. I assume you have already bought back in or are in the process of doing so.
Crazy thst investors who bought a few weeks ago now need a 100% increase from current SP just to break even. Looks like we have another buying opportunity today :)
One thing I have come to realize over the past few weeks is that after more than a decade we have finally approached the 'make it or break it' juncture. The outcome may not be what many of us desire, but at least we will have final resolution soon. IMO there are 3 possible outcomes. 2 of the 3 will conclude this endeavor as we know it today. The 3rd (and least likely) will keep the dreams alive. Good luck to the longs.
Options are always a gamble RK. I hope you make some back. GL
If I had to guess, I would say that Dan was inferring that typically the 1st I/A would wait for full enrollment, but the DMC may have decided to have a looksee before full enrollment based on the "encouraging" data from the info arm. Or..I could be way off
You are probably right. The wait is tough..it has been a long one.
I'm holding for the big payoff, like NW. Well I guess if you are going short it's a signal to go long. It's been like clockwork ever since you started posting. The most recent when you "warned" everyone to buy puts as a hedge. I bought as many calls as I could. We both know how that turned out :)
Here we go again I guess. You don't have any more insight than anyone else as to the long term success or failure, but your short term predictions have always been the pyrfect contrarian indicator. I would guess we start a move up soon.
Wow you are right about your timing being terrible. Didn't you notice the sp was above 12? Why wait until the 7's to short? You had the German protocol (that "wrecked your model") weeks before the SP went above 12. Do you really think what you are saying this morning will fool investigators? Lol.. carry on
Maybe LP has a little mid-day PR surprise planned.
Last year you were as certain DCVAX would blow SOC out of the water as you are now that it will fail. NWBO was a "once in a lifetime" opportunity with all of the little glimpses into efficacy before the trial results.
Do you think we are all too stupid to see through the bs? Do you think we really believe you "found new evidence" that changed your opinion so drastically? The only difference this year is the person writing the check. Sad, but true. I don't know what the outcome of this trial will be (neither do you), but I do know with certainty some of the games that are being played and the people involved.
You can say what you will about LP, but I can assure you of one thing. LP and Woodford are very powerful people with a lot of connections. Few grasp the size and reach of the network and resources that exist for the elite. Have a great day!!
It's great to have an all knowing prophet here to help us prepare for the future. Isn't this the same L version that the 55 info arm are receiving? Okay, great, thanks!
I refuse to conclude this is unrelated to current events.
"A Memphis biotech firm will add up to 80 jobs after a $9.47 million expansion of its offices and clean room.
Cognate BioServices Inc.’s permit filed with the city-county Department of Construction Code Enforcement shows 32,500 square feet will be added at 4600 E. Shelby Drive.
The need to ship and receive samples at a moment’s notice was the main reason the company chose to place its plant in Memphis, close to the FedEx global hub.
“It’s a strategic location,” Stella said. “Memphis was chosen for its logistics infrastructure and its centralized location to the United States.”
Plans call for completing the expansion early next year, Stella said..."
Please summarize what he posted so the rest of us can see it.
Senti there is a big difference between blinded and double blinded trials. Do you remember if you mentioned double blinded when asking your questions? LP was very adamant they had not seen any efficacy data from the trial in comments last year.
Found this abstract on Pubmed http://www.ncbi.nlm.nih.gov/pubmed/23957516
Is there any chance the temporary halt is simply part of the interim analysis protocol as per the trial design?
Abstract
In clinical trials, interim analyses are often performed before the completion of the trial. The intention is to possibly terminate the trial early or adjust the sample size. The time of conducting an interim analysis affects the probability of the early termination and the number of subjects enrolled until the interim analysis. This influences the expected total number of subjects. In this study, we examine the optimal time for conducting interim analyses with a view to minimizing the expected total sample size. It is found that regardless of the effect size, the optimal time of one interim analysis for the early termination is approximately two-thirds of the planned observations for the O'Brien-Fleming type of spending function and approximately half of the planned observations for the Pocock type when the subject enrollment is halted for the interim analysis. When the subject enrollment is continuous throughout the trial, the optimal time for the interim analysis varies according to the follow-up duration. We also consider the time for one interim analysis including the sample size adjustment in terms of minimizing the expected total sample size.
And just what exactly does a DMC look at during a futility analysis?
"I am not ashamed to admit that I am of the opinion that a halt for efficacy is the most probable outcome of this trial, by far, and soon. Probably in less than two months, and possibly in less than one (according to my working theory)."
But it's okay with me if it takes longer because:
"using an "interim" look of a trial to begin the process (after it has been analyzed) to petition the FDA for accelerated approval happens, at the interim look (where we were not long ago). Of course, the results have to be tabulated, analyzed, and then the petition sent to the FDA, then discussions ensue, then the FDA deliberates, then delivers their decision = significant time lapse. The only good thing about this time lapse (and as per the quote above), is that the data that accumulates in the ongoing trial during this time (in our case, events 67-?), can actual BECOME the "post approval confirmatory trial" data normally required post AA. Thus, we may get an AA, and then full approval in quick succession."
Or this?
"concurrent with an early halt for efficacy, if that should happen. It's rare, but if the treatment is showing very high effect with statistical significance, it would be deemed unethical to continue all the way to the end. Statistical significance with a trial powered such as this one could possibly be achieved this summer (60% events had occured in Dec). It's a real possibility.
Our discussion on AA was short. I showed you FDA guidance which stated a process by which a company would file an NDA or BLA for AA using an interim analysis as the basis, while the trial continues to satisfy the post AA confirmatory trial requirement. You, my friend, are the one who refuses to get it. FDA wants to see a confirmatory trial IN PROGRESS when granting AA. Why? So many of the companies granted AA drag their feet thus for many years, while taking full advantage of their newly acquired marketing capabilities. FDA is changing the way this works. It appears they are wont to demand a conf trial in progress before they consider AA. One way around this, is to use the interim data of a larger Ph III trial as the basis of AA, etc... :
"When it is possible to use a later effect in a trial to verify the effect seen earlier in the same trial that supported accelerated approval, the same clinical trial(s) can be used to support accelerated approval and verify and describe the clinical benefit. In this case, the protocol and the statistical analysis plan should clearly account for an analysis of the surrogate endpoint data to provide support for accelerated approval, with continuation of the randomized trial(s) to obtain data on the clinical endpoint that will be the basis for verifying the clinical benefit. When the same trial is used to support accelerated approval and verify clinical benefit, the data to verify the clinical benefit may be, in some cases, nearly complete by the time of accelerated approval."
Does anyone remember this?
"A recent FDA guidance states a process by which a company would file an NDA or BLA for Accelerated Approval using an interim analysis as the basis, while the trial continues to satisfy the post AA confirmatory trial requirement.
FDA wants to see a confirmatory trial IN PROGRESS when granting AA. Why? So many of the companies granted AA drag their feet thus for many years, while taking full advantage of their newly acquired marketing capabilities. FDA is changing the way this works. It appears they are wont to demand a conf trial in progress before they consider AA. One way around this is to use the interim data of a larger Ph III trial as the basis of AA, while data collects as the trial continues to satisfy the post AA confirmatory trial requirement:
"When it is possible to use a later effect in a trial to verify the effect seen earlier in the same trial that supported accelerated approval, the same clinical trial(s) can be used to support accelerated approval and verify and describe the clinical benefit. In this case, the protocol and the statistical analysis plan should clearly account for an analysis of the surrogate endpoint data to provide support for accelerated approval, with continuation of the randomized trial(s) to obtain data on the clinical endpoint that will be the basis for verifying the clinical benefit. When the same trial is used to support accelerated approval and verify clinical benefit, the data to verify the clinical benefit may be, in some cases, nearly complete by the time of accelerated approval."
This is the path that was followed with Eloxatin:
"In 2002, oxaliplatin (Eloxatin) was granted accelerated approval for use in combination with 5-FU/LV on the basis of data from a randomized, three-arm study of oxaliplatin plus infusional 5-FU/LV versus 5-FU/LV alone versus single-agent oxaliplatin in patients with advanced colorectal cancer refractory to first-line treatment with irinotecan and bolus 5-FU/LV (21). The study enrolled 821 patients and had a preplanned interim analysis after 450 patients were enrolled. At the time of this interim analysis, a response rate of 9% (13 of 152) was observed in the combination arm compared with a response rate of 0% (0 of 151) in the 5-FU/LV arm (P = .002). Patients in the combination arm had an approximately 2-month increase in median time-to-progression (4.6 months, 95% CI = 4.2 to 6.1 months) compared with patients in the 5-FU/LV-alone arm (2.7 months, 95% CI = 1.8 to 3.0 months)."
The study was not halted early, and was granted AA after the data from the interim analysis was used as the basis for their NDA application. The time in which this occurred saw the trial continue, accruing data to verify clinical benefit."
Please stick around flipper. We need you to help combat the rampant manipulation and deceit. Maybe now more than ever before.
How do I get my hands on the L trial protocol? It seems like some here have it. Will someone please share it?
Check this out! From a UK clinical trial for elective abdominal aorta aneurysm (AAA) repair. This research article was just published on August 25th. The patient recruitment section is of particular interest. Maybe a temporary suspension is mandatory UK NIHR protocol during an interim analysis.
http://www.trialsjournal.com/content/16/1/377
Results
Patient recruitment
In total, 98 patients were referred for an elective AAA repair (71 EVAR and 27 open procedures) during the 2-year study period from 1 January 2011 to 31 December 2012. Of these, 93 were screened for inclusion and 85 (91 %) were eligible to take part. Fifteen eligible patients were not approached for the trial:
1. Three because the surgery was cancelled (patients with significant co-morbidities where consultation at the multi-disciplinary team meeting and patient choice led to the decision not to proceed).
2. Six for logistical reasons (staff shortage; initially not enough backup when study principal investigator (PI) was absent).
3. Six because the trial in patients undergoing an EVAR procedure was temporarily suspended while the results of an interim analysis was reviewed.
And once again Les's statement:
"The only change is that new screening of patient candidates is temporarily suspended while we submit certain trial information for regulatory review."
This morning I re-read Larry's May 1st article, Northwest Biotherapeutics: FDA Panel Recommendation to Approve Amgen’s Cancer Vaccine is Hugely Significant In Regard to Possible Approval of DCVax-L and DCVax Direct. Good stuff!!
http://smithonstocks.com/northwest-biotherapeutics-fda-panel-recommendation-to-approve-amgens-cancer-vaccine-is-hugely-significant-in-regard-to-possible-approval-of-dcvax-l-and-dcvax-direct-nwbo-7-86-buy/
This is useful info. Thanks Luna!
The current 'uncertainty' could also be used to the upside in the coming weeks. Might get interesting if a couple of large funds or hedgies decide to jump in on the long side. Perfect time for a firm like Baker Bros. to initiate a position and open the floodgates of bandwagon jumpers. Maybe that's just wishful thinking, but you never know.
See his message today on the ymb. Also, one of the not so bullish posters had speculated a similar date previously on IV. Interesting that both sides seem to agree the screening halt was in effect in early August.
Recent evidence provided by RRR from conversations with several of the trial hospitals validates that the screening halt was implemented around August 3rd, more than two weeks before it was publicly addressed by NWBO. This is huge IMO and strongly supports the idea that the screening halt was not initiated by a regulatory agency.
If it had been initiated by a regulatory agency, LP would have been required to disclose it to the public as a material event IMO. The long period of silence after the screening hold was put into place and the fact that the trial status was only addressed when it unexpectedly became visable due to the EU system glitch may be be the strongest evidence in ruling out certain negative scenarios that the lawyers at NWBO would have been forced to disclose long before August 21.
I've had a little time to process everything and have a couple of thoughts on the recent events. In the first PR, NWBO stated "The Company is in the process of preparing the trial information for regulatory review and anticipates submission within the next couple of weeks."
For some reason this just isn't what I would expect as a response to a safety issue. Oh hello FDA. What!?? We had a grade V SAE death in the trial? Okay, we’ll get back to you in a few weeks… Yeah, I don’t think so.
Combined with these statements “Those who would try and misrepresent the status of NW Bio's programs are at it again. False impressions have been widely spread today...” (emphasis mine)
What did we hear about nonstop when the screening halt was first announced from our short friends?? Safety and futility. Remember, the only two explanations as to what is going on. I wonder if those two scenarios are the ones address in the “False impressions have been widely spread today” comment. Would they really say that if it were a safety or futility issue? Prudent to consider they have had over 1000 L treatments without a safety issue.
I suppose it would have been easy enough for them to rule out any safety concerns in the PR. However, it would make sense that they are being very careful not to tip their hand on ‘positive’ developments in the trial. My guess is that there are very specific rules and procedures to maintain the trial integrity before or during a regulatory review.
Also, is it possible information from the other L trials could be submitted for AA?
Hoping Larry Smith will weigh in now that he is back from vacation. I always appreciate his perspective and comments.
Anyone with just a little common sense can review the 2014 PR's about Direct and immediately see that the nwbo legal team covered everything and clearly stated the results were early in the study and not conclusive. That's why there hasn't been any legal action in over a year. The fact that the ambulance chasers and media are still bringing this up like it's a new concern only shows are desperate they really are.
http://www.bloomberg.com/news/articles/2015-08-27/itg-suspends-trading-operations-due-to-issue-at-data-center
Wow! I sure hope all of the data from the dark pools was protected. Would sure hate for millions of short positions to suddenly disappear. Haha, the things conspiracies are made of..
Hope nwbo finishes the week strong!!
Hi TC. Anything interesting going on with the trading the past couple of days?
Wasn't a jab and I haven't been a basher. Unhappy long at times? Yes! The MACD has been a wonderful technical tool this year and I am hoping for a crossover. Should have listened to the sell signal. Didn't want to be out if our train happened to arrive in the coming weeks. Waited too long to risk that occurring. Darn hindsight..always so clear.
C'mon MACD crossover..
Hmm..maybe there are more than two possibilities to what is going on :) Any thoughts on NCT02146066?
"We must put it together."
So put together the possibility that enrollment was halted because it is complete (counting the pipeline) combined with the fact that data is being submitted for regulatory review. What other possibilities do you come up with? Why not write a bullish hypothesis or two (just for giggles)? Can we completely eliminate the first IA occurring if we assume enrollment is complete?
Gem of a find. When will the shorts wake up and realize the predicament they are in? Short interest back up to 9.8m as of 8/14.
"Fully enrolled by Summer of next year"
NWBO affirmed today they currently have over 300 enrolled in the trial. There is other evidence that they have been enrolling at a higher than expected rate over the past few months, but I don't need to do all of your DD for you. Maybe you should reconsider your two scenarios theory and leave room for the possibility of something else going on with the regulatory review.
He's too busy to take your call. They are cooking up a little surprise for the shorts.