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Regarding AFs concern about this only being a case study:
"The Company plans to announce further case study information prior to the annual ASCO conference..."
And
"...the Company also plans to provide overall information about the data to date by the time of the ASCO conference."
So the company knows there is a difference, and they plan on releasing more of BOTH before ASCO.
Wow, such fear in the market today. Understandable i guess. Only human.
You know what Warren Buffet would say. Load up (ie "be greedy when others are fearful")
Good luck all.
$BNYC
Can anyone square the following statement for me?
"Immune therapies generally work much more slowly than chemotherapy or targeted drugs, so it is especially encouraging to see any such signs so soon."
YET when they first announced the trial, they said how they were expecting results quickly. I remember the PR said something like, "tumor regression, if it happens, will be seen within the first few months of injection"
Is this not sitting well with anyone else?
Long NWBO.
Thanks.
"The Company plans to announce further case study information prior to the annual ASCO conference..."
"...the Company also plans to provide overall information about the data to date by the time of the ASCO conference."
So....we will know a lot more about DIRECT in the next 2 weeks then? Excellent.
Thank you to the entire NWBO team, the patients and their doctors and this board.
DOWN WITH DISEASE!
$BNYC
Wait im wrong. Embargo was today. Sorry.
4) If no data allowed to be released, then why is there a data embargo leading up to the event? All of our abstracts are embargoed until May 14, 2014 at 5:00 PM EDT, this is something that the authors agree to when they submit to ASCO. See our policy here: am.asco.org/first-author-responsibilities-0
5) Abstract #TPS3133 … to be released on May 14 at 5pm eastern? Or: not until day of presentation = June 1? All abstracts will be released on May 14 at 5:00 PM EDT. The only ones not released are plenary abstracts and those deemed LBA (late breaking abstracts).
Embargo lifted tomorrow (thurs) at 5pm, from what i understand.
"What is acceptable in a Trials in Progress abstract and poster?"
Just so we temper expectations for tomorrows abstract release...i figured id repost the details about our poster.
NOTE: The ***** are all mine for emphasis.
So hopefully we will get info on trial enrollment numbers and such tomorrow. But IMO the important event occurs this Thurs at 5pm when the ASCO embargo is lifted.
$BNYC
-----------------------------------
What is acceptable in a Trials in Progress abstract and poster?
Scientific background/rationale for the trial. Preclinical and/or earlier-phase clinical data that has already been publically presented or published may be included with references.
**** The Trials in Progress session should not be used to present preclinical or earlier-phase clinical data for the first time. ****
Trial design and statistical methods, highlighting any novel aspects of the design
Treatment or intervention planned
Major eligibility criteria, highlighting unusual aspects
Correlative studies of particular interest
****Current enrollment without providing results or endpoints ****
Enrollment must have already begun or have been completed with no data analysis available by the February 4th deadline.
Phase I studies may say, "Cohorts 1 and 2 have been completed without DLT. Enrollment to cohort 3 began in January 2014."
Phase II studies may report, "8 of planned 32 patients have been enrolled" or "Prespecified activity goal for the first stage of accrual was met; second stage accrual began in January 2014."
Phase III trials may report, "The DMC last reviewed the trial in December 2013 and suggested that the trial continue as planned."
Clinical trial registry number (required)
*******What is not acceptable in a Trials in Progress abstract and poster?
Any preliminary data including toxicity, response rate, pharmacokinetic, or correlative analyses. NOTE: Abstracts including results or preliminary data will be rejected without further review. *********
Exciting times. ASCO Abstract is released tomorrow. But IMHO it will pretty much tell us what we already know.
BUT MORE IMPORTANTLY the ASCO embargo gets lifted on Thursday. After that, anything is possible. Fantastic news about DVAX DIRECT could come at any time, or not at all. Yikes.
Then the ASCO conference at the end of the month where they have quite a lot of booth space in the convention hall (for some reason).
Meanwhile NBWO owns www.CancerVaccine.com (for some reason)
And it is actually approved to get DVAX-L in Germany legally and safely by paying full price. (for some reason)
Plus our CEO owns many many shares herself (for some reason)
Ok ill stop.
Avg volume today but stock up 10%. Shorts covering? Hmmm. Quite a risk to be short right now, especially after Thur 5pm. But I'm sure they'd say it's a risk to be long. Thats what makes markets.
And shorts have done very well this past month. So congrats shorts!
Well, good luck to all of us in all different situations. Go NWBO!
DOWN WITH DISEASE!!
$BNYC
"Doctors use patients immune cells to shrink cancer tumors" (NYTimes May 8)
Not NWBO (as far as I know) but still....
http://www.nytimes.com/2014/05/09/health/doctors-use-patients-immune-cells-to-shrink-cancer-tumors.html?hpw&rref=health&_r=0
DOWN WITH DISEASE!
-$BNYC
Hi. Where do you see the info about a 1.25 financing? Thanks.
What is a Form T-Trade?
There is much confusion and rumor regarding “T Trades” in the penny stock market. Nasdaq Pink Sheet stocks often close at a certain price and, within 3-10 minutes after the closing bell, will show a large final trade that gets labeled as an “after hours” trade. Simply put, this is an inaccurate description of that trade.
To understand how this trade works, one must understand the role of the market maker. The most frustrating aspect of investing in the pennies, is market maker manipulation of the stock price. Anyone that claims this manipulation doesn’t happen truly does not understand the OTC Market. Market makers are in place to “control” the price of a stock and, theoretically, to ensure that the market reacts properly to supply and demand for a certain stock. Unfortunately, when large sums of money and a lack of regulation are involved, more often than not, there is manipulation that suits the needs of certain investors or the market makers themselves. After all, they are in business to make money as well. If the average investor is purchasing stocks in the OTC Market, that investor is truly at the mercy of the market makers involved in the purchase and sale of that security.
When researching this article, The response from the SEC defined a “Form T Trade” a “trade reporting form used by broker-dealer members of the Financial Industry Regulatory Authority, Inc. (FINRA) to report equity trades executed either in the OTC market or during extended hours trading. Recent amendments to FINRA rules will expand the types of situations in which Form T is to be used, but they are not yet in effect.” The response also recommended contacting FINRA. Notice the first portion of the response. “either in the OTC Market or…” Once again, it is confirmed by the SEC that ”after hours” trades do not exist in the Pinks.
FINRA was much less transparent in their response and essentially spewed the same limited information regarding T Trades that is available on their website. None of which, accurately reflects why these trades occur in the OTC Markets. (http://www.finra.org/web/groups/industry/@ip/@reg/@notice/documents/notices/p123750.pdf)
Trying to decipher the meaning of these trades with the limited information that is available on the subject led down several dark paths. Clearly, the average investor is not meant to understand the concept or its rules. Even more disconcerting is the second part of the SEC message “Recent amendments to FINRA rules will expand the types of situations in which Form T is to be used, but they are not yet in effect.” That means there is even less transparency about this mysterious T Trade.
After months of due diligence, there are a few poorly publicized uses for a T Trade. The most important factor here is that the only requirement of market makers by FINRA is that they must report all trades in a day. They are not required to do so when the actual trade occurs.
To avoid creating “an unbalanced market”, market makers often do not report certain trades during the day to the public and then use a T Trade not to “scare” investors into thinking a market for that stock is going in one direction or the other at the spurring of one large investor.
If a market maker wants to accumulate a large amount of a stock in one trading day, that market maker may actually not report any of the trades that occurred until the trading day has ended so as not to alert the market to the collection. This practice is completely legal under the FINRA rules of the OTC Markets so long as the trade is reported at the end of the day.
To execute a Market on Close” order, a market maker may have an order to purchase the stock at a certain price at the end of the trading day. This is the most unlikely scenario because it needs to be assured that someone selling the stock and someone buying that stock are agreeing upon a price. Simply put, this is more likely with insider buying and selling.
The T Trade that the public sees is nothing more than one or all of the above scenarios. The T Trade reported at the end of the day can be from one market maker or many involved market makers. It can be a single purchase price but is usually an average of all of the previously unreported purchases from that business day.
Penny stocks are an exciting and lucrative business. As most everyone will tell you, it is not for the weak of heart. There is definite money to be made in the OTC Markets and more penny stock millionaires are made every day. But the best way to win the game is to know the rules!
One additional fact surfaced about market makers while researching T Trades. Did you know that market makers are not required to honor their offer price? That is correct, because the OTC market is essentially a “best offer” market. If a buyer meets the asking price for a security, the market maker can, and often does, decide to rescind the offer, not sell the security and adjust the selling price.
Afford, "allowed to be discussed"? There is no "discussed". She clearly stated it's not an "oral presentation". It's just a 14inch poster. But my point is OK GREAT let's all forget about the abstract and the poster. It's secondary to the truth about Direct which will hopefully be revealed after the EMBARGO is lifted on May 15th 5pm. Then they will have all that space at ASCO for when they "expect to have a lot to talk about," as Linda stated (I'm paraphrasing). Yes they will talk and yes they will discuss results (hopefully), but none of the results will be in the fancy 14inch poster. Big deal. Can we move on from the abstract/poster and towards the light??
"Light bulb" indeed highwayman!
Please someone call me out if my theory/expectations/ass-u-mptions are way off.
SBNYC
First, it's not even an oral presentation. It's just a 42inch poster. Second, the fancy poster can't have any preliminary data on it.
"Any preliminary data including toxicity, response rate, pharmacokinetic, or correlative analyses. NOTE: Abstracts including results or preliminary data will be rejected without further review. "
But my point is BIG DEAL. They'll have their very large space and they'll have their mouths and the press releases, (hopefully) released after May 15th 5pm because of the EMBARGO! Let's forget about the abstract and the poster. It's only the appetizer. Its the drink before the appetizer!!!
Hopefully THE TRUTH (about Direct) will be an entree and dessert like we've never tasted before. (NoPump) and hopefully we can eat after May 15th 5pm. We're all very hungry, no??
Yes yes Mr Vator??
SBNYC
Fantastic Evaluate. Thank you. I pasted the TIP guidelines below from the link she gave. So since it is indeed a TIP it seems our poster can include preclinical data in mice (80%-100% of mice cured with a systemic effect) but NOT current or preliminary data in this human trial. I figure that's fine, whatever. Perhaps the poster is secondary, meaningless even. Here's why:
Since the "embargo" (I love that word) gets lifted on May 15th 5pm, can we ass-u-me that NWBO will be shouting from the mountain tops after May 15th 5pm to build up great interest so they "have a lot to talk about" at ASCO plus all that space they bought won't be a complete waste?? All that space for a 42inch poster about preclinical data they've already released?? They must have a better plan than that!
The poster is probably secondary, a side show....the real show will be, "come to our booth, check out our awesome cancer vaccine DVAX Direct that you heard about on the news. Oh yeah and check out our poster." (Sorry getting a little ahead of myself - not trying to pump)
Besides, we are definitely due data. In announcing this trial, since it is UNBLINDED, they said in the PRs that data would be known very quickly - before the end of 2013 even - as reduced lesions either happen quickly or not at all.
So let's ass-u-me they definitely know right now whether it works or not. So after may 15th 5pm they really have no excuse not to tell us (ie shout it at us)...unless they haven't even started the trial yet, but I don't think that could possibly be the case, now could it?
So May 15th 5pm or bust? Guess I'll go about my usual routine till then. Good luck to all NWBO investors and the incredibly brave patients and brilliant hard-working doctors in the trials.
Embargo!
SBNYC
Trials in Progress Poster Guidelines
Size Limitations: No larger than 42 inches high and 42 inches wide. This is half of the size of the poster board. Do NOT exceed half of the size of the poster board.
What is acceptable in a Trials in Progress abstract and poster?
Scientific background/rationale for the trial. Preclinical and/or earlier-phase clinical data that has already been publically presented or published may be included with references. The Trials in Progress session should not be used to present preclinical or earlier-phase clinical data for the first time.
Trial design and statistical methods, highlighting any novel aspects of the design
Treatment or intervention planned
Major eligibility criteria, highlighting unusual aspects
Correlative studies of particular interest
Current enrollment without providing results or endpoints
Enrollment must have already begun or have been completed with no data analysis available by the February 4th deadline.
Phase I studies may say, "Cohorts 1 and 2 have been completed without DLT. Enrollment to cohort 3 began in January 2014."
Phase II studies may report, "8 of planned 32 patients have been enrolled" or "Prespecified activity goal for the first stage of accrual was met; second stage accrual began in January 2014."
Phase III trials may report, "The DMC last reviewed the trial in December 2013 and suggested that the trial continue as planned."
Clinical trial registry number (required)
What is not acceptable in a Trials in Progress abstract and poster?
Any preliminary data including toxicity, response rate, pharmacokinetic, or correlative analyses. NOTE: Abstracts including results or preliminary data will be rejected without further review.
Proprietary drug names
Absolutely. I thought I was drinking the Kool-aid when I bought ALNY at $7 3 years ago (400m market cap then - $4B now).
And I feel the same way with NWBO....am I the fool here or is f-stein?
Time will tell of course, but I didn't bet the farm on ALNY and I ain't betting the farm on NWBO either. But I'm IN for as much as I can afford to lose.
Why a 350m market cap? I totally agree with you and I totally get why it should be in the billions, but Wall Street says, "show me the money." And I think it's all about the uncertainty of the phase III trial. There is still heavy risk/unknowns that keep the price down. Perhaps your assumptions should be in check. If you assume absolutely nothing, then how do you arrive at billions anyway?
And remember the f-stein rule? Over $300m is the proper level of a successful phase III trials, so maybe we are sitting pretty. Germany and Direct are future potential with a lot of uncertainty and misinformation. Plus, people are confused about Germany and how it will affect the US trials. I think the market cap reflects the current reality of this company, NOT the future potential and that's ... OK.
Plus please realize that many many many shareholders own this stock at 3.50 (including me).....so there's lots of partial stock holdings to be sold at 8....and that has nothing to do with market cap. That has to do with human beings (including me) wanting to take a little off the table.
But if in 3 months (or 3 weeks or 3 days) this stock has a billion dollar market cap, then you'll be satisfied, right? So be patient, it will come. With everything that's KNOWN right now, 300m is fine with me. But to steal from Donny Rumsfeld, there are many know unknowns and unknown knowns and unknowns unknowns.
I don't know if I'm helping or I sound like a fool. Either way, good luck to everyone.
DOWN WITH DISEASE!
$BNYC
Thank you for sharing your friends story Swamp. I dedicate the shares I picked up today to him. Is there a charity in his name perhaps? I invest in biotech because I never want to hear stories like that again. It makes me so angry even as I sit here in tears.
GLTA
SBNYC
Huh LTT? No tangible revenue from Germany?? They can now "charge full price", there will be "reimbursement" and "In the meantime, patients may SELF-PAY for DCVax-L."
From recent PR DATED March 10, 2014:
"Under this Hospital Exemption, NW Bio may provide DCVax-L to patients for the treatment of any glioma brain cancers (both Glioblastoma multiforme and lower grade gliomas), both newly diagnosed and recurrent, outside of the Company's clinical trial and CHARGE FULL PRICE. The patients may be from Germany or elsewhere."
"The amount and terms for such reimbursement will now be negotiated by NW Bio, the hospitals and the Sickness Funds over the coming months, and will be applied to patients case by case. In the meantime, patients may SELF-PAY for DCVax-L."
Just bought more NWBO at $6.72. Wow, what a day so far. Biotech getting hammered. Looks like I'm on a shopping spree this week. Next up, buying more INO. Looking for $3! GLTA.
SBNYC
Swamp, I wanna give you some biotech recommendations but since this is the NWBO board, I should probably first discuss my reasons for being long and heavily weighted in NWBO:
1) German approval leads to US/UK approval of DVAX-L, 2) NWBO at ASCO is gonna be a huge event, 3) DVAX-Direct works. All IMOH (In My Own Hoping) of course.
I actually woke up this morning and thought that if DVAX direct works in humans as it did in animals, NWBO might one day be $1200/share, which would be a $50B Market Cap. Then I made coffee.
Now NWBO investors can stop reading if they want. Swamp, here are my recommendations:
My favorite biotech "stock of the century" is INO.
After that, I'd recommend looking at ONCS, CGEN, TLOG, CVM. But that's only for immunology, what you asked for.
For stem cells, look at ISCO, NBS, ACTC, CYTX.
For RNAI, look at RXII.
And it seems like you should put a little in ELTP - special thanks to DRante.
I've been in biotech for 20 years. My biggest win (so far) is buying ALNY a few years ago at $6.90. I'd be happy to talk to you further about any of my holdings.
But I like to tell my friends, I know nothing, I'm only human, and I'm expecting to lose some money in the stock market betting on the future of medicine and human survival. So good luck to everyone. And my best to all the people and their families stricken by these horrible afflictions.
Down with disease!
SBNYC
Moose, with such a thoughtful well developed opinion basis for NWBO I'm surprised you didn't mention DVAX-Direct or the ASCO conference in June (the massive amount of space they've reserved - WHY?) and the abstract they submitted to present there.
DVAX-Direct could end up being the real money maker in all of this. Does it work? We'll have to wait and see. So perhaps it's not even a consideration now as to the PPS but perhaps it should be. That's why I bought more today. But I've been buying since last summer. Good luck to all!
Crawford, have you or anyone else heard of ISCO (Int'l stem cell corp). I believe they licensed iPS cells from ACTC, they are testing it in primates now for Parkinsons and are planning human trials for Parkinsons in 2015. I'm long both ACTC and ISCO. Anyone else?
From Crawford's post:
"However, there is no doubt this is a very exciting area with huge potential. My husband, Jun Takahashi, is planning on carrying out a safety trial of a treatment for Parkinson's disease based on IPS cells in two years time. I don't know if he can do it, but he says he can."
LASER SAFELY DESTROYS DEEP BRAIN TUMOR, CA FIRST
Tuesday, February 25, 2014
UC San Diego - Health Scientists
Newswise — Using a novel magnetic resonance imaging (MRI)-guided laser technology, neurosurgeons at UC San Diego Health System have successfully treated a malignant tumor deep inside a patient’s brain. This is the first time that this FDA-approved laser-based treatment has been performed in California.
“The patient’s brain tumor was located in the thalamus. Normally, to access a tumor in this region, the surgeon would have to remove considerable healthy brain tissue, thus subjecting the patient to significant neurologic injury,” said neurosurgeon Clark C. Chen, MD, PhD, vice chairman of research, UC San Diego Division of Neurosurgery. “This MRI-guided laser technology helps neurosurgeons preserve healthy brain tissues while allowing treatment of tumors that would otherwise be inoperable.”
Chen and his team used a technique called laser interstitial thermal therapy. The procedure is performed inside an MRI machine while the patient is under general anesthesia. A dime-size hole is created in the patient’s skull to access the tumor. A laser probe is then inserted into the tumor under real-time MRI monitoring and computer guidance. When the tumor is reached, the laser beam is activated, heating and destroying tumor cells.
“It is well-known that MRI can be used to generate detailed images of the brain. What is less known is that MRI can also be used to measure the internal temperature of the brain,” said Chen. “With this application, I can view the tumor in real time as it is being destroyed while customizing the effects of the laser to the tumor without injuries to the surrounding normal brain. This incredible visualization allows neurosurgeons to preserve billions of neuronal connections that are essential for normal brain function.”
Many types of brain tumors can be treated using this laser technology, according to Chen, including glioblastomas, anaplastic astrocytomas and brain metastases. A comprehensive risk-benefit analysis is conducted for each patient to determine if a minimally invasive or open-approach is best suited to the patient’s specific tumor type. Chen added that his goal in all procedures is to destroy the brain tumor while maintaining the highest quality of life for his patients.
Patients undergoing thermal ablation are typically discharged from hospital one day after the procedure and can return to normal activities. The laser ablation requires real-time MRI monitoring and a dedicated intra-operative MRI team. The procedure cannot be performed in a conventional operating room.
The NeuroBlate® System was developed by Monteris Medical, Inc., Plymouth, MN. The NeuroBlate System is also used to treat epileptic disorders and chronic inflammation caused by ionizing radiation.
To learn more about treatment options for brain cancer at UC San Diego Health System, please call Sharon Pretorius at 858-246-0674.
Original Article: http://www.newswise.com/articles/laser-safely-destroys-deep-brain-tumor-ca-first
What's with the confidential order that was announced by inovio today? Anyone care to guess what THATS about?
So wait...if the # of shares outstanding was about the same as now (approx 30M), then the MARKET CAP was $510B back then (pps $17,000)? That cant be right, can it? Cmon now....
I will NOT be able to sleep tonight. At least tomorrows Friday. Go NWBO! Not for my bank account, but for the entire human race and all families affected by these horrible diseases. FYI I was long IMUC and VICL too
Currently long: INO, ALNY, RXII, CVM, CGEN, ROSG, NYMX, ISCO, ONCS, NWBO
2014 or BUST!
-SBNYC
Great new interview/article. Mentions NWBO, CYTR, INO (Im long on those) and many others.
http://jutiagroup.com/20131217-the-new-year-heralds-a-transition-in-stem-cell-development-jason-kolbert/
Just listened to yesterdays webcast by Linda. Loved it. (Go to nwbio.com then investors then webcasts.)
News still to come in 2013. That could be: 1) compassionate use allowed in Europe, 2) more sites are added for their dvax-direct product (testing in all solid tumors - unblinded - just started, taking time to find right dose - patients knocking down door to get access). 3) manufacturing expansion of dvax product in us/Europe.?
News in Q1 2014: PIVOTAL first dvax direct update
Summer, 2014: pivotal blinded GBM trial gets unblinded and reported.
Also: dvax prostate is approved for phase III, just need a partner.
And dvax -ovarian tested on humans to good results but only 6 patients and they were at end stage.
They're gonna need to raise money in 2014 but with success that won't be an issue.
How is it that NWBO and NLNK are both presenting Tue Dec 10 at 1:35pm?? Seems odd. Anyway, long on BOTH!!
Reminder, big presentation this Sunday:
CARLSBAD, CA--(Marketwired - Jun 27, 2013) - International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com) a California-based biotechnology company developing novel stem cell based therapies, announced today that it will present preliminary data from its IND-enabling study in Parkinson's disease at the Society for Neuroscience annual meeting in San Diego, CA on November 10th 2013.
The Society for Neuroscience is the world's largest organization of scientists and clinicians devoted to understanding the brain and nervous system. More than 30,000 people are expected to attend the annual meeting, making it one of the largest scientific and medical conferences in the world.
Reminder, big presentation this Sunday:
CARLSBAD, CA--(Marketwired - Jun 27, 2013) - International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com) a California-based biotechnology company developing novel stem cell based therapies, announced today that it will present preliminary data from its IND-enabling study in Parkinson's disease at the Society for Neuroscience annual meeting in San Diego, CA on November 10th 2013.
The Society for Neuroscience is the world's largest organization of scientists and clinicians devoted to understanding the brain and nervous system. More than 30,000 people are expected to attend the annual meeting, making it one of the largest scientific and medical conferences in the world.