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My first impression is that:
110: PFS Events
is equivalent to
72: OS Events
In that the same language is used for these 2 milestones, however, the 60%, 80% interim analysis language is not used for OS.
I think the latter was an oversight, so let me try to fill in the blanks to get the ball rolling.
OS: First Interim Analysis = 44 events.
..Second Interim Analysis = 58 events.
Of course if this is correct, it means there will be twice the number of interim analyses if the trial goes to primary and secondary endpoint completion. You can again multiply that number by 2 when you add the pseudo progression group.
Hmmm.
E.5.2.1 Timepoint(s) of evaluation of this end point
Overall survival will be assessed when 72 deaths have occurred.
--Evaluate
Pyrr said.
Hey flip, I had a brief discussion with Larry on SA and he seemed to be of the same opinion as AVII that the DMC hadn't even begun looking at the data (though for differing reasons). -- PYRR
Back on April 16, 2014…..
Larry Smith thought the DMC would likely resolve the delay issue within a month or so. I think we are in a very critical window for L, and I personally would not be surprised to see a recommendation before June 1, 2014.
I should have placed this in the present tense.
Regarding possible upcoming PRs, I can only say NWBO made it sound like more [ARE] on their way in quick succession.
BB promised himself he would no longer post on any board if one of his predictions did not occur.
Regarding possible upcoming PRs, I can only say NWBO made it sound like more were on their way in quick succession.
Thanks John.
How reliable is Sierra?
A 'Chronological Crescendo' perhaps. Information intensification. Public Relations Escalation. Building News Bulletins. Critical Mass Correspondence. Associated Press Ascension. Surging Scoops. Climaxing Communiques.
I researched it further, and it appears different studies use different definitions for "extensive necrosis." Still, it's something that NWBO might clear up between now and (at) ASCO.
There's a hole in bucket dear Liza.
I wonder if that dog knows his owner got the bucket and a free bowl of soup for entering a raffle…. Apparently not:)
Now, if we could get a conference camera on the dog.
Thanks. That was a 401 class level answer. I really appreciate it.
Fascinating.
I would say buy a few extra shares just to trade so you can profit from what they'll do - as opposed to trying to go head-to-head with them. -- OU
That is why I have asked for help. I think Long and Ou are better equipped to give an accurate answer. I often go beyond my knowledge base, but in this case, it just makes sense to ask the right people.
Here is a revenue chart for NWBO through the fall of last year. (I do not believe NWBO receives compensation for every treatment in Israel, mostly because it is still experimental; however, I am not the expert on this specific topic.)
http://ycharts.com/companies/NWBO/revenues_ttm
I have asked LongUSA for assistance in interpreting the more recent 10Qs found in the SEC filings.
You are far more experienced than me, but let me answer #2 first. That is relatively easy.
IMO, Answer #2 = 100 to 250 PPS on the day both events were announced -- increasing beyond that.
IMO, Answer #1 = Too difficult to tell, but here is the technique the hedge funds use upon a huge announcement (and let me say that if both of those PRs were announced on the same day, there is very little the hedge funds could do.) Hedge funds would also buy all the way up, and at the top of day 2 they would buy short positions. Then they would sell almost all long positions they bought all the way up in very large blocks, all the while making 'paper' money on their short positions. (Again, if the scenario was as presented in your hypothetical, I don't think we'd need to worry a great deal about a hostile takeover based upon the weeks and months of attention NWBO would garner.) Anyway, upon getting the price down to some level with their large block sales, they would then convert their shorts, and sell those in large block sales to try and drag the price down further. They would combine the large block sales with efforts to discredit the findings with incestuous media hit pieces suggesting revenue is a long way off, attack management for one reason or another and distract potential retail investors with sparkly alternative companies that actually have no meat on their bones.
That is why we need a conference camera on TZOR's head. I'm still chuckling over that. I think it would be very bizarre for LP to leave the ASCO Pavillion on June 3, 2014 without providing some early numbers on revenue from Germany.
It can be obtained in Israel for approximately $110,000.
That is approximately $36,667 per year for three years. I do not know the price in Germany at this moment.
The German and NWBO reimbursement negotiators, in my opinion, are dialed into everything that is currently going on with ASCO, Direct and L. From earlier studies on this subject, the German price reimbursement will be locked in for a number of years once it is set. This price then becomes the keystone for other EC countries who discount based upon their own GDP, and increase based upon transport and preservation considerations.
So, you could probably make a call to NWBO or the PEI to find the current price, but I can almost guarantee you that it will not be the ultimate negotiated price.
Thanks Pyrr.
This is a case of me expecting the best, but planning to prevent a hostile takeover if that window opens.
We will probably see another cap raise in Q3, unless more warrants are exercised. If a robust revenue ramp starts in Germany (my expectation is start in Q3), this would moderate cash needs. LongUSA
We must be vigilant. (I don't mean to sound too dramatic) Even a halt for efficacy, if that comes to pass, can be negatively spun with enough purchased media firepower. Hostile takeovers are well planned events.
I do not want the follow up to "Who Killed the Electric Car?" to be "Who Killed the Cancer Cure?"
(Again, excuse my drama.)
At some point….not today, but at some point if evidence becomes overwhelming, I will try to strike up a campaign of sorts for investors to tell their friends, family and others about this stock.
I am normally someone who never gives advice on stocks to friends and family, because I believe professional brokers are far better equipped to give sage diversified advice.
Here is why I may consider breaking my own rule/code in the future.
I think several large hedge funds control enough shares in aggregate to tamp down moderate positive price movement on NWBO. (I expected this for over a year) Over time, not yet, but over time this could provide a very destructive effect on NWBO expansion, PPS and dilution. This in turn would make NWBO ripe for a takeover.
Right now, each time good news comes out, the AF, Carrol and similar camps tamp retail and institutional purchasing down with hit pieces. This is compounded by hedge funds pulling out previously purchased shares to tamp down any price acceleration. Certainly none of us want any unnecessary financing price dilution, but over time we all agree that biotechs must frequently raise cash until they start producing enough revenue on their own.
The ideal situation is where the "rational speculative" price (yes I used rational and speculative together as a term of art) and market cap are so large that the financings have less impact on fully diluted outstanding share percentage. If this does not happen when the good news we are anticipating starts flooding in (because hedge funds keep dropping the price back down (perhaps as a surrogate for a large pharma hostile takeover [yes this actually happens folks]), everyone else is a loser.
Consequently, not today, but at some point it may be necessary to start an investor informational campaign to friends, family and Billionairs (hey why not?) to prevent NWBO destruction by Hedgies.
If that day comes, I hope you will consider joining forces.
I really liked your analogies. You included a great deal of helpful information. Also, thank you for the patient example. Good luck on your submission! See my PM for more.
We are fortunate to receive case studies leading into the conference.
Remember that slow period? Look at the current numbers.
This is not a trial with 5,000 patients and a company reporting on one patient. This trial (in my best estimate) is somewhere between 20-30 participants currently receiving injections (with 10-15 of those patients too early in the process to have data available yet). -- Hodge
One of your best Pyrr. The last paragraph confronts mortality and hope.
Make that 2 patients.
That made me laugh at loud:)
LTT, no matter how this goes, please stick around after ASCO and L results. I think a debriefing amongst admitted shorts and longs would be a healthy exchange. Right now, everyone has too much riding on outcome. Let's watch some game film for next season. Until then, I think most people are committed to their positions.
Your logic checks out.
Thank Heavens!
and may you and yours receive continued and permanent blessings.
Ou.
I saw this with Medarex a few years back. They had big news about patients with tumors that had shrunk, but it wasn't trial data. CNBC carried the story pre-market…. The stock rallied briefly and then ended up only slighty. It was a great buying opportunity and the company was eventually bought out. But I was puzzled why the stock didn't move more. I still don't understand it. I know we need more data (from both trials) to get NWBO to take off, but I added today - both pre-market and in the regular trading. -- Ou
Great question, and while I certainly can't speak for the company, I'll try to explain this in short order.
NWBO's first nonspecific tumor lysate platform product was/is DCVAX-Brain (aka:DCVAX-L). Since 1999, it has been tested on GBM patients. It is administered sub-dermally.
The results for DCVAX-L are most notably measured by 'overall survival' (OS) and progression free survival (PFS). In the case of DCVAX-L, Provenge, ICT-107 as well as other dendritic technologies, the influence on OS and PFS becomes more evident 2-5 years after treatment when compared with control groups and/or historical standards. This is what is known as the "Long Tail."
So when NWBO's PR from today states,
"Immune therapies generally work much more slowly than chemotherapy or targeted drugs, so it is especially encouraging to see any such signs so soon…."
Chiugray said:
10 days until ASCO and 6 cancers, one already PR'd. If Direct works on all, theoretically a PR every other day, next one Monday hopefully. (Of course 6 PR's would be my wishful thinking...)
Hi Long.
You have to admit NWBO chose the road less traveled. I hope it makes all the difference!
My guess is that the PR today is just a way to build up to better news to come. --StockFollower
I owned a little stock for a while (cytx). When some very good news came regarding financing, the shorts were willing to engage in a 15 million dollar one day battle to tamp down the price increase. The company was/is smaller than NWBO.
A number of years ago, Cramer admitted he'll spend millions just to change sentiment by rapidly taking bids, etc.
There are parasites trying to change your perceptions. Sentiment seems like such an innocuous word, but Cramer confessed he made his millions (and consequently crushed others) by simply modifying sentiment. In some cases he'd spend millions to set things up, in others he'd call his media friends and ask for hit articles and beyond that, he admitted on videotape no less, that he would just lie to save a hedge fund position.
A few months ago, Diamond Jim reposted Cramer's confessional videotape that demonstrates how deep pockets with large megaphones try to modify your sentiment so that they win and you lose.
Exactly Hodge!
I'm excited to learn about the other case studies that will be presented. I'm assuming they would be saving some even stronger data leading up to ASCO (if I were running the PR team anyways).
Don't lose sight of the fact that the biopsy (which was done at just 8 weeks) showed substantial tumor necrosis and t-cell infiltration. -- Hodge
It appears AF will attack cancer patients for the next 2 weeks. How would you like to be fighting for your life and at the same time labeled "EXPLOITED" by AF? AF is a lost soul.