Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I appreciate your post dearly which are pure, full of information/knowledge and inspiration if I am reading it under any other circumstances other than where we are which you have depicted precisely in terms of company affairs and share price.
But I don't think you or any other long-term significant share holders should have written such posts simply because there are existences of the people like AF [it's my opinion moderator, and a fact, not personal attack; if you have any doubt ask AF].
It is a battle. If you reveal too much, including the mood of us investors, you are losing!
The very hard and cruel reality is I have accumulated share counts never ever I would want to imagine because of what we have gone through which you depicted it accurately.
And I have refinanced one of my homes in Florida and get ready to get in even deeper if share price deteriorate further from today's.
The shares I bought in $0.33 ~ $ 0.42 range have enabled me to make even at around $1, which I am comfortable it will be there soon.
Ever never in my > 30 years investment in biotech, I have accumulated this many of shares in one company. But I am happy (with tear now) and confident it will pay off.
My target is still $30 in one year and more as time goes after that.
Cheer!
Sorry, those statement is in quotation marks and is not in my writing. It is from the original poster who I don't want to reply directly.
People know I don't normally directly reply to any posters who are deemed to be not genuine and instead have agenda. So I start with this new post:
Someone has once again (repeatedly) revitalized an old already rebutted debate hoping to inject FUD again, perhaps to new investors in regards to "difficulties" in identifying pseudoprogression, specifically how to read patient MRIs.
He said he is not a radiologist but instead suggests he is better than a radiologist in reading MRIs.
He took two points (two MRIs) with one showing tumor at its growth peak (2wks after 3rd vaccination, which is about 5wks) and the other showing tumor completely disappears (4month, or 16 wks postvaccination).
For a wannabe like him without any experience and training as oppose to a real radiologist with training and experience, he naively compare the two conveniently while blatantly ignoring this is a process or a transient process.
Tumor came back from detectable mass to peak mass at about a little above 1 month (or 5wks), and then started diminishing until 4 months (16wks) when it was completely gone.
Any reasonable person, let alone an experienced radiologist would observe such a process, or make an inquiry into such a process, and indeed into the transient nature, and determine it is actually a pseudopregression by itself, or during the process or observation that tumor was disappearing over time or helped by new MRI.
Not everything is just black and white, but our convenient posters, including AF would want you to believe otherwise.
Even, in this case, it is also likely some pseudo-progressions may have been wrongly determined, but the majority of the cases should be caught by those experts involving in the trial.
Again remember, noting is just black and white. The "world (the issue here)" consists of not only two conveniently cut out points. As a matter of fact, the world is flat if you look just around you!
So let professionals do their job! the following in quotation mark is a post I indirectly reply to:
"
I suspect your issue is with the "transient" nature of the response; it goes away after 4 months further follow-up.
" Quote:I'm a radiologist.
I can tell you that he is wrong, FACT
Very convincing.
Nothing to back your assertion up except an appeal to authority.
I do believe that you are a radiologist.
It is obvious though that you have never served on a clinical endpoint adjudication committee.
In a clinical trial like this one, the scans will be sent to blinded radiologists who will strictly apply the pre-defined criteria to determine if the scans should be catagorized as progressive disease or not.
Someone shared the criteria here previously. They said:
Quote:
DEFINITION OF PROGRESSION AFTER ENROLLMENT
Progression, calculated from the nadir tumor burden (i.e. post operative, Baseline, or Baseline 2), is defined as one of the following:
• In the case of complete resection during primary therapy: a new measurable tumor at the site of the resected tumor, defined as a mass with a longest diameter equal to or greater than 1 cm in at least one dimension. If progression is not defined by these studies, treatment may proceed and determinations made at the next scheduled MRI.
• In the case of incomplete resection during primary therapy: a 25% increase or greater in the residual tumor if the recurrent portion of the tumor is at least 1 cm or greater in its longest diameter, measured by MRI and confirmed by scans above as attributable to tumor growth;
• If resection is indicated for recurrent disease, while radiographic criteria for progression have not been met: surgical resection, subsequently confirmed as progressive GBM by Pathology at the clinical site and to be confirmed by independent pathology;
• Appearance of any new lesion/site at least 1 cm in at least one dimension or greater measured by MRI and confirmed by scans above;
• Unequivocal progression of non-measurable disease (either non-enhancing disease seen only on T2/FLAIR images or enhancing disease not meeting size criteria for measurability), such that there is confidence that tumor growth has occurred;
• Death: all deaths are counted as events for the primary endpoint.
Quote:
So, what don't you agree with?
Does this MRI show a mass larger than 1 cm in area?
Does this MRI show a >25% increase in mass?
It's obvious the scan represents both. It is a textbook example of progression at that time point.
I suspect your issue is with the "transient" nature of the response; it goes away after 4 months further follow-up.
But if that's you view, you are ignoring the fact that the only mechanism in the assessment criteria for examining subsequent scans is in the case of equivocal findings.
And this scan in not equivocal. It is unequivocal? It shows both a >1 cm mass ("measurable") and a >25% increase in mass size. A textbook progression event.
[MRI images in the link below:]
http://www.investorvillage.com/uploads/81923/images/MRI-NWBO.jpg
Perhaps you are unaware of the recent EMA findings relative to the AVAGLio study in nGBM (the very same indication). They noted:
"The SAG also commented on the long survival observed for numerous patients with early progression and concluded that this finding was counterintuitive and possibly a further indication of the lack of clinical meaningfulness of the PFS adjudication criteria used in the study."
That sounds a lot like this patient. Early progression and long survival. That's the hallmark of pseudo-progression. (Come to think of it, it's also the same thing seen in the "Info Arm": early progression and long survival)
Why did the AVAGLio radiologists classify them as early progressors (and not wait to see if it resolved later)?
Because they strictly applied the adjudication criteria.
And you had better believe they will also strictly apply the adjudication criteria in this Phase 3 trial with DCVax.
"
Yes, but D can serve as a cushion. I have called on the company a long time ago to conserve cash and focus on completing L trial.
If no advantageous offer from any big pharms on collaboration with D and/or L such as significant upfront payments, etc, let it be, and do wait for the completion of L.
The quietness of over more than a year regarding L should continue if the company has not obtained any fruitful resolution on numerous and various suspected and reasonably understandable fronts:
1) Seek approval of L according to original and/or modified protocols, meaning, demonstrating ss > 4 months of PFS difference plus some OS benefit, either ss or not;
2) Seek approval of L according to original and/or modified protocols, meaning demonstrating that L indeed provides OS benefit even if it misses its primary PFS target (I don't see why FDA would not approve L if, for instance, the company may have enrolled about 330 patients around Oct last year, and the trial can demonstrate median OS 18 months of the control arm versus 28 months of the treatment arm. But if the trial can demonstrate ss 22 versus 24, that may be tough if the trial miss its primary target);
3) If the company can establish a reasonably solid correlation between identification of a subtype and clinical benefits, although it may not be included in the original protocol, if that relation can be reasonably established, I don't think FDA would have any hard time to approve L for that specific population;
4), 5), ...
I believe the above process is on going alone or concurrently. It's a long wait, but it is definitely approaching a resolution if not today and yes you bet tomorrow.
Shorts have been covering but still in denials thinking they will have enough time and can time the market (or simply they just cannot cover their huge naked short shares without wakening the general market which will in turn bury them significantly underwater) while the general market has not yet had a serious look at this company for so long.
When thing changes, it will be a tsunami.
I also think this is the most likely case. Everyone should put pressure on SEC,FINRA, etc via various means, including directly reporting / request, social media, etc, asking investigation into suspected naked shorting scheme spearheaded by KCG, etc against nwbo on behalf of itself and other 13 hedgefunds (the wolfpack) (name them if you suspected who they are), which may spearheaded by KCG, UBS, etc.
GLTA!
FACT: Woodford Is An Insider! Just like LP, LG, etc., he can buy shares but he must follow relevant security laws and regulations, and he cannot buy anything if he has material information.
Whether he has signed a NDA or not doesn't make any difference because he is an insider.
Period.
BTW, thank Mav for your reply and this is my last post for today.
GLTA!
Keep in mind that cart-t is only suggested with strong efficacy or even cure with blood cancer (non-solid cancers) and has never been successful in even a hint on treating solid cancers.
DCVax platform is different and has been shown potential efficacy or even cure (combination or not) for solid cancers.
As for safety 100% agree with your assessment on Cart-t.
Short (the legal short part) keeps increasing:
Settlement Date Short Interest Avg Daily Share Volume Days To Cover
9/15/2016 12,494,238 4,752,024 2.629246
8/31/2016 11,253,732 1,219,595 9.227434
8/15/2016 10,876,277 697,992 15.582237
7/29/2016 10,792,259 619,565 17.419091
which suggests the illegal part has been even more in deep in a hole which is so large that the shorts can never cover.
Wow, I love it.
Of course, with a big news, and a lawsuit against the naked shorts, the wolfpack.
Very well written regarding the recent affairs.
As long as partial halt for additional patient screening is concerned, it may have nothing to do with the screening per se in the first place; otherwise it would be solved in due time.
Just want to add to your excellent summary:
Public traded companies, big or small, do those independent internal investigations into their own affairs all the time, due to either internal or external pressure.
Almost all would not report the findings publicly and instead they would make appropriate (correct) actions either due to the requirements of compliance or otherwise.
In the case of nwbo, I think the process is still on going, but the company has actually revealed some investigating results via SEC filing:
1) the company has hired additional personnel to improve on its financial affairs reporting, including 10Q, 10K, etc, to further separate duties from LP in this front;
2) Yes, the MFN clause has been removed to align LP's interests with those of investors;
3) the company has hired additional independent directors to strength the board;
4) the company has paid off all its money owing to Four M in accordance with their patent-in-trust agreement so now the company is in full control of its patent portfolio.
As a matter of fact, all the outstanding issues detected by auditors have been all solved except one item (what specifically I don't recall at this time).
So the company has moved forward positively toward a company with good governance.
I guess if LP has no confidence in the future of the company, it would be no reason for she to have implemented the above.
Yes, the company has strongly suggested the L trial has been moving toward completion for months now since Q2 report. It is a strong possibility that the results of L trial may be available in the near future.
Ya right brother. It's all noise and it will be abundant until our day.
We are in a foxhole with no way to go but fight, and shorty wolfpack will be dearly surprised and run like the ones in the video:
This news release is a steppingstone if the company has learned a valuable lesson.
I believe it is just that.
More to come.
Good bye for a while.
Hi Hopefulsurgon,
Better not have too high expectation on such scheduled events, like conference. It may be just usual activities after long hot summer: people just get back work.
If the theory or theories are intact, which dictate why the company has been quiet for over a long year, then no reason to believe there will be any earth-shattering news from such conference. Simply it cannot be scheduled in nature.
But any day now on, there could be a day LP receives a call from FDA, thereafter accompanied by letter. Then, she has to be report to the public in a timely manner, usually within a couple of hours to a few days, and the sooner the less of trouble down the road.
and/or, LP may eventually get something moving in regards to HE in Germany. If that is the case, after signature, it will be announced. This one may be of a schedule event, so are those long anticipated partnerships deals. Again these are anytime now events.
But, we do know as of today, that D will give some definite sign on correlation of treatment to survival (the poster event on 26 Sep in NY), and hopefully maybe some other surprise too.
As far as share price is concerned, IMHO, this time is probably different than what we have seen before, meaning the price will be most likely held, though may still be some ups and downs. The reason is implied above:
Time wise, concrete news may be broke anytime now, either related to L or D or both, of regulatory nature or partnership deal, etc. In addition, the huge volumes of the past week is a strong sign of no return regarding share price.
BTW, I suspect LP has med Neil in London.
BTW2, I also have tons of Jan'17 options ranging from $3 all the way to $10, which I have long treated them valueless. But I do hope some earth-shattering news would revitalize these options for me. I also have tons of '18 options.
BTW3, I am very happy to add substantial shares to my already large position all the way from $6 down to heavy activities in the range of $0.4 ~ $0.33.
Good day and luck.
Contact the media and spread the information to anywhere significant you can reach, like biotech focused hedge funds, etc.
Nwbo is not listed in NASDAQ stocks with the most traded volume and price increase today. I have contacted it. Even it makes correction it is useless for today but we can keep eye on NASDAQ in the future for fair and accurate information.
As a matter of fact, nwbo is the company with the largest percentage increase today, and among the top ten with most traded volume.
Until the price reaches the range around $5 ~ $8 before the release of the good news on L success, the market in general owes a justice to it.
Great work md1225. Thank you.
I guess if one is really a long investor, it will be much better to do the same as you have been doing, contact the media and analysts, just providing information in any ways possible.
GL
Before he does that, he has to solve a fundamental problem of his: insomnia.
Anyone with such an incessant load of hatred, negativity, and idiocy can not sleep well at nigh, let alone have a sane mind.
So he should stop taking useless medicines and instead start cultivating a healthy pattern of personal conduct.
Then, he will once again enjoy a sound sleep and see the light at the end of tunnel.
Trust me, it's a blessing if you dare to give it a try.
My statement "a few hundred of millions of naked short shares" should be read as a half hundred of million of naked short shares.
Sorry for the rash and good evening.
Just had some time going through Smith's 9 Sep analysis on NWBO. Before I discuss my takeaway from reading it, I need to disclose that I am not a fan of either Smith or AF, but their analyses, though vastly different in styles and contents can often serve as a starter for a more in-depth DD on any underlining stock.
Now let me list my takeaways:
1) His speculation on safety concern as the initial reason for FDA's involvement and its subsequent temporarily halting of additional patient screening is amateur, contrary to his established status as a seasoned biotech analyst. While the whole retain world, long or short has moved on and away discounting that as the reason, his pickup of that as a reason is very detrimental to his career, his reputation, and in general his judgment;
Usually, upon such a concern, if there is a real case such as a death, or a severe advent event or two, etc., FDA would immediately ask the company to stop treatment, and launch a relevant investigation, or to provide information such as a protocol change, etc, in order to reasonably persuade FDA not to imperatively place a hold, or impose it and lift it immediately after reviewing satisfactory investigation results or persuasive information.
FDA would never act like a detective to investigate into the actual matter! So he seems to live in other planet for some reason;
2) His repeated assertion regarding the urgent possibility of insolvency or bankruptcy due to constant short of operating fund is once again of an amateur in nature, much contradictory to his established status; perhaps he has exhausted his means in trying to find something, but he would be better keeping quiet if he has nothing meaningful to say;
Of course, in a midterm or long term, dilution is a real possibility (it is actually happening); Reverse split is also a possibility (although the company has said it is not considering it in the short term to midterm), but to say the company may be of bankruptcy as the results of its pivotal L trial have yet to be known and its promising D trials have yet to be launched is again laughable and naive;
3) In regards to what the share price would be look like if L is a success, he seems to forget his certainty in large short interests, including a few hundred of millions of naked short shares, and the term of short squeeze; In addition, with the news on a positive trial results, the dam now holding the water will be readily collapse; bears will be readily killed; bulls will be running again in stride; new bulls will willingly come inboard, particularly those with deep pockets (institutional investors, new or old). With that certainty, analysts will count their fingers and come up with some real picture of how much money can the company make in short term, midterm and long term, and they will publish it after their masters have taken a position.
Then, it’s the time for Joe and John in the main street to come to the wall street as new investors as the successful story is told and broadcasted repeatedly in various colors and angles.
These are just my takeaways, and I have no intention to engage in any kind of debate. Also, I hope moderators would not deem this post "off topic."
Patients deserve something new and effective; long investors deserve something in return for their long enduring of hardship; shorts having had a reward of profit for a whopping long year deserve something unforgettable in life if their greediness has blinded their eyes.
Again, it does no good to engage in any discussions with the known shorts or those working with shorts.
GLTA!
Back from trip. My previously set buy order at $0.28 still stands, and I cannot help but buy additional tiny 25k shares today at $0.33.
I plan to go offline most time waiting for results, not any insignificant ones.
For me only news I want to hear is whether L is a success; whether D and/L will be partnered with big pharms or not if L is a success, whether Woody and/or other long institutions are once again on board or come on board?
Besides all the above, I would like to see the company come up with evidences and go after those naked short bastards.
BTW, it's better not to engage in any conversations with known shorts (or those who work for shorts) in any way.
May patients have an effective treatment soon, and may all of you longs a happy and lucky future!
Thank you too md1225 and also other longs for making this board worthy of coming back to read.
BTW, I find LP's trip to Germany on 22 Sep intriguing in that she will be presiding a session with a short five minute introduction, and it seems that's it, almost immediately after her presentation in UK on 21 Sep.
What's she up to? Does she just once again waste shareholders money?
It is ok either way for me, to hear anything or nothing since I have been tempered to be a patient man, although not in my nature.
Good luck and good holiday!
Back from vacation, and tomorrow will be on a small trip again. Have read some posts but no time to catch up all posts.
It seems at this point of time, waiting is still the game.
It's no surprise a few posters always talking nonsense, or should I say convenience or FUD. Such things would never change and that's part of their game. For instance, someone is talking about dropout as if it is a big deal. It seems the guy has never designed anything in his life except messing up on somebody else's designs. What a waste of time!
Anyone who wants to design a project, he or she must first have a goal. For instance, If one wants to run a clinical trial aiming to enroll 348 patients, he or she must taken into account a reasonable dropout rate in design before actually enrolling the first patient, either it is 5% or 20%. It is a common sense, but there you go of one more convenience FUD poster or wannabe, actually in this case: an EX + wannabe, even worse.
So in the case of nwbo, the target number of 348 patients must have taken into account a reasonable dropout rate before that number was put out there for anyone to see. Anyhow, the number 348 is a targeted number, meaning it is not imperative. As long as the designed primary target and secondary (probably now a co-primary target since trial expansion) target are satisfied, the world will have a new proved treatment!
Have to prepare my small trip tomorrow. Good labor day and good luck to all longs!
BTW, I set two batches of postdated buy orders before vacation at $0.33 and $0.28. Of course, the one at $0.33 was filled.
Wow, people are debating journalism, professionalism and good deeds in regards to the Streets, and in particular AF.
Nonsense, he doesn't in any way strive for a Pulitzer. Let all useless debates a break. The streets and AF are struggling for commercial gains, either directly or indirectly.
In regards to white collar criminal activities, no countries in the world in history have ever been effective and will never be effective.
Faced with this reality, it is no use to debate.
I hope Linda has long realized this, and that is why the silence, at least part of the reason, that she and her team have worked hard behind the scene.
Since damage has been done and the share price has been grounded, I also hope the company will not release any "useless" information and report under pressure, but only those of significance.
I also hope the company should consider merger with Cognate, now or later so that various accusations regarding conflicts of interests can be made null.
Despite indexes and mutual funds, etc., have dumped all their nwbo shares as the price dropped below $5 and $1, and the share price today is around $0.4, the short interests are still around 11 million shares (the actual number is much higher if naked shorting is taken into account). Based on this, I suspect the portion of nake shorted shares must be so high that shorts have realized they have been trapped even by taking into account their significant insurance warrants.
Don't think AF's showing up in this board at this time and his sticky attack on this company even as the share price of the company is in the penny territory is anything personal.
No, it is commercial. I bet he still read this board and his twitter, contrary to what he has announced in his twitter in regards to his vacation this week.
All have to remember he has a political science degree. Judged by that, he is doing pretty good in his job.
Below is one article you wrote regarding Global Blood. In that mirror combined with what you have done regarding nwbo, you will see what kind of a person you are. Enjoy!
https://www.thestreet.com/story/13610860/3/biotech-stock-mailbag-cascadian-therapeutics-global-blood-therapeutics-bad-favus.html
"In this biotech bear market, good news is sold, especially if a company's good news follows an anticipatory run-up in stock price. A follow-on financing, or just the hint of one, is another reason to sell.
We got all that with Global Blood Therapeutics in the past week. The stock moved higher ahead of the anticipated data update on the company's sickle cell disease drug GBT440. The new GBT440 data presentation last Friday was positive, even if the number of patients treated remains small. Then, Global Blood followed up with a $100 million shelf registration filing, leaving investors with the impression -- accurate or not -- that a follow-on stock sale was coming. And it did, on Monday, with the company announcing a $100 million offering expected to price Monday night.
In the past month, Global Blood shares have gone from $18 to $27 and back to $18. With the overhang of stock offering cleared, Global Blood shares were up 10.7% to $19.75 on Monday.
I don't like Elliot Favus. Pardon my bluntness, but I think he's a jerk.
Why? Because Favus has tried to get his lawyers to stop me from doing my job.
When one of his short-selling reports -- sent privately to his hedge fund clients -- causes a biotech stock to fall significantly, it's my responsibility as a journalist covering biotech stocks to explain to readers why the stock is falling. That's called news, and I'm in the news business.
Favus and his lawyers don't like when I write about his research reports or even mention his name in a tweet. His lawyers send me threatening, cease-and-desist letters. TheStreet's lawyers send letters back, telling him, politely, to back off.
A lot of people dislike Favus because he writes short-selling research about biotech stocks. I admire him for that. I love a good bear thesis. You know this about me. Short sellers play an important role in the markets, which is especially true in biotech investing where the flim-flam can be piled high. Favus provides an important counterweight to much of the overly optimistic sell-side research published and consumed every day.
But I also dislike Favus because too many of his reports are poorly researched and intellectually dishonest. Take, for example, Favus' most recent report on Global Blood and GBT-440 published on last Wednesday morning. Favus believes GBT440 is a zero.
"The sum total of the GBT440 data in sickle cell disease strongly suggests the drug is not active," Favus writes, adding that Global Blood shares should not trade any higher than the company's cash value of $4.50 per share.
Favus might be right about GBT-440 not working in sickle cell disease. Global Blood has certainly not studied the drug long enough yet to make any definitive conclusions about its efficacy or safety. But in reaching his conclusion, Favus cherry-picks data presented last week on GBT440. He raises some good questions, but ignores data which works against his bear thesis. He also flings some amateurish accusations at the company better suited for a message board than an institutional research report.
Favus accuses Global Blood of hiding 90-day data from the 900 mg dose cohort, but Global Blood said those patients are still being treated. The data will be presented in December at the American Society of Hematology annual meeting.
To Favus, the "sum total" of the data is GBT440's effect on hemoglobin levels in sickle cell patients. He raises a legitimate concern about the variability of measuring hemoglobin. But he also totally ignores data on other blood-related parameters like bilirubin and reticulocyte counts which support the drug's efficacy and back up the observed increase in hemoglobin.
In his report, Favus excoriates Global Blood for not having data on patient quality of life or real-world outcomes like reductions in painful vaso-occlusive crises.
Global Blood "has been presenting investors with (mediocre) GBT440 lab-test endpoints from a small, single-center trial, when in fact, the FDA approval path for a new drug for sickle-cell disease must include QoL data and outcomes data (number of pain crises, hospitalizations, transfusions, etc.) which GBT has been totally silent on," Favus writes.
This is misleading and factually wrong.
Global Blood's current study was designed specifically to assess GBT440's effect on blood parameters because those are the objective data easiest to collect from a small and relatively short study. The patients enrolled in the study have relatively mild sickle cell disease. More than half of the patients treated with GBT440 in the study had zero hospitalizations for painful crises in the past year. Only 18% of the patients were being treated with concomitant hydroxyurea, the only medicine approved for sickle cell today.
Given this mild patient population, it's unrealistic, even ridiculous, to expect Global Blood to show a meaningful reduction in painful crises or hospitalizations. Favus is smart enough to know this but he hammers the company anyway.
And Global Blood acknowledges openly that FDA will require positive patient outcomes data in order to approve GBT440. This is no secret. The company intends to design a registration study to gather these data.
And then Favus goes off the deep end.
In his report, Favus accuses Global Blood of being the "Theranos of drug companies" because two directors on the board have no drug-development expertise.
Nine directors sit on Global Blood's board. Two of these directors -- former San Francisco Mayor Willie Brown and former Massachusetts Governor Deval Patrick -- are not "biotech" guys. And for this, Global Blood is Theranos?
Really, Favus? "
Filled 5k at between 0.39 and 0.4 for my overseas account. Now still have 4k at bit of 0.4017 for sometime now. This one is just for entertaining with shorts. See how it goes. Hi shorts, please dump that tiny 4k to my please.
Thank you Turtle for your kind words. It is a testing time and I think we will pass it handsomely. Best Wishes.
Doc Logic, I agree with you 100%. If that is the case, the existing protocol may require a minor modification. But if it is in totally the hand of FDA, the change may not be required.
Hope this may turn out to be a truly unprecedented case in history, and if that happens, I will be retire early, much earlier than would be expected.
Good night and good luck.
Hi Doc, I don't think a time driven analysis is likely in this case, and I agree with MD's opinion.
I think the key for the trial is to detect statistically significant benefits/advantages of DCVax-L over SOC. So definitely a certain number of events is required for the detection of ss difference.
One other point I want to point out is that although the targeted enrollment is 348 patients, it is not imperative, and as long as ss PFS and/or OS can be detected, FDA will approve it.
If the trial goes extremely well (well I should say "extremely bad" if it bests the designed parameters by a large margin), the company may request and FDA may agree to have an analysis when a much lower event number is reached such as 72 OS events (which is the original number required for OS analysis before the trial expansion), instead of today's 233, or somewhere between 72 and 233.
Lastly, unless one believes Linda is indeed a crook and a reckless criminal with nefarious motive, he or she should not believe Linda has withheld or hidden material negative information about the reason for the partial screening halt, including major manufacturing issue (a minor one would not take more than a year to resolve), safety issue (all now agree this is just nonsense), or futility (another nonsense), because in October last year and January this year the company has publicly said it has not been aware of any change which would justify significant share price drop at the times, etc. After all she must have been an idiot if she had withheld and hidden such material negative news simply because no one can hide a piece of news in such magnitude for ever.
BTW, the short interests reported today for 31 July from NASDAQ show once again shorts have continued covering although in a slower pace. Maybe it becomes more difficult for the shorts to find those shares to cover.
Good night and good luck.
Sorry, I cannot reply to most of the posts. I only have three posts a day and this is the last post for today so I would like to say thank you all for your kind words and companies in this long and arduous journey towards a resolution, a dream becoming true practical therapeutic cancer vaccine and a rewarding investment.
The current year-long partial halt for screening additional patients surely invites various speculations, but some seem reasonable while others not. Bottom line is we all speculate based on our own judgments, and what has actually been happening surely is much more complicated.
Still it seems waiting is the only game today after a long year of waiting, and I thank God for giving this testing time to me.
Good night and good luck to you all!
I try to be polite today so Outside Lane won't find any reason to delete my post:
Since I don't want to tangle with any persons I deem to have no genuine intention or interests in this company, I would just like to point out one of the earliest speculations on the reason for the temporary patient screening halt in case people have forgot it:
DMC contacted FDA reporting extremely low event rate, which is much lower than expected;
FDA reviewed the information submitted by DMC and asked the company to halt screening for additional patients upon further notice while it conducts an investigation on what has really been going on and asking the company for some information ("certain information from the trial");
Confirmed the abnormally low event rate for OS, FDA takes its time waiting for more patient accruals (OS events) so that it can draw a reasonable conclusion with certainty;
The abnormally low event rate suggests patients in overall or in average live longer, much longer than would have been expected (recall LL's words?), which would be unethical to continue to enroll any additional patients since some patients would be put into the control, which would be likely inferior to the treatment arm;
In the meantime, the company cannot do anything but wait for FDA's decision. It cannot say the reason either because if it does, any patients already in the trial would have the right to ask whether they have been in the control arm, and if yes, they would have the right to ask for immediate access to DCVax-L vaccine. As a result, the trial would be ruined (or compromised)!
Any direct hint on the issuance of partial halt by the FDA would invite more questions as why, when exactly, etc., and the company may have to answer, which is exactly what the company won't do.
And this may be exactly why there has never been a definite information on the reason regarding to the current ongoing partial halt for additional screening, kind of "intentionally making some murky water" at the ire of investors.
The speculation above is today still one of the most reasonable theories on the reason of the halt, and yet some people are more than willing to forget it.
It explains why it has taken so long and it still seems to be no end of it.
Patience, ladies and gentlemen. It is out of control of anyone including FDA.
God willing, let patients live much longer than would be expected.
"The current development regarding FDA's order to stop Juno's pivotal P2 trial due to deaths of patients has a very significant meaning regarding the future landscape of cancer treatments:
Cart-t as a group may have run into corner as the investment world finally come to a long overdue conclusion: this class of treatment is dangerous, cumbersome and costly, and its benefit/risk ratio is so unfavorable.
CI as a class has shown some success with very limited treatable patient population due to its nature.
Increasingly, more and more people will realize DCVax as a therapeutic cancer vaccine platform will emerge as a new and more broad blockbuster cancer treatment class due to its pristine safety profile and potential significant efficacy; with combinations with CIs, the platform may be potentially a cure for some cancer indications.
At this point of time, anyone who is debating on the purpose of debating is obviously naive or up to something that a normal investor will not do. So please stop engaging in such distractions, either from an old topic which has been discussed before with no new meaning but endless new speculation; something to do with fine prints pulled out from company's sec filing which have been covered in the previous discussions; and any other FUD such as tailored, sometime out of context copies and pastes of some selected FDA documents, and ambiguous subjects such as comparing a "lackluster device" to a potential blockbuster cancer vaccine treatment in any angle negative or ambiguous possible, etc.
The bottom line is if DCVax-L or D is proved to be better than any existing treatment in any indication in terms of safety and efficacy, it will be approved by FDA; even if L or D might be shown similar in efficacy and/or even safety to that of any existing treatment, it will still be approved by FDA as an alternative which can applied for specific patient populations.
While one may get carried away from a useless debate, he or she must always remember that at $0.5 a piece per share, basically the market has priced the company a failed company, the L trial a failed trial, LP a failed ceo, and all long investors failed hairballs, and nothing less.
Don't tell me the company will go bankrupt if you are genuine and have a bit biotech experience, only if LP had nefarious motive if you believe. A company like nwbo will not go bankrupt at foreseeable future, though it is a likelihood that the company will survive simply by diluting its existing share holders.
Nonetheless, as long as the potentials of D still exist, as long as there is still likelihood that L may still be used in combinations with other agents such as CIs even if L is proven a failure in brain cancer indication, a market cap of around $100 million will be normal, which will give you roughly $1 per share of stock price.
Not saying the company has not filed a BLA (rolling application or not), not saying the company has not sought AA, but what I am saying is the current situation indicated by share price has totally denied any possibility of those and regarded the company a failed company with a failed L trial.
It is then a natural, logic, reasonable and certain conclusion as long as investment is concerned: buy nwbo shares as many as and as much as one can afford at this option price.
It is either $0.5 loss or $30 gain or $300 gain.
It is my strong belief that there will be a major short covering coming within the next few weeks judged by current ultra-low share price (it should have never been at such a low price, no reasons, absolutely not), the closeness to a major revealing of many optional developments in the company, and the current on-going change of tide shifted from cart-t and/or CI toward DC-based therapeutic cancer vaccine treatment (cure) (note: it is my speculation)as well as the general trend of money inflow to biotech, which is on going.
Because unless shorts have bullets penetrated their heads making them totally blinded, a major short covering must be and will be coming, even if I prefer it not!"
Shorts indeed are in the process of covering. In order to control the price after some covering, they short some to maintain a price. My broker loaned out some 50k shares siting in my margin account to an unknown short a couple of weeks ago (who the hell would short at $0.5! Well shorts who started covering would just do that. Anyhow I will ask those loaned shares back in the near future). And new funds have been poured into small biotech like crazy though nwbo has not yet been benefited, but how long can this situation remain the same? No long, my friends.
Good weekend and good luck longs.
He lives in the short world, and it is paid.
AVII, you seem to be a smart cookie but since when you have relied on your "unbiased excellent analysis" on another "smart cookie" who has been proven to have a swinging view depending on what position is taken.
BTW, her statement has been refuted repeatedly last year when it came out. You don't verify your sources, smart one? As it is well known, shorts don't care about truth or fact but convenience.
So I would suggest you go dig out what the original source of this LL statement, and listen to it yourself. After you do that, you would understand her statement is at best a misunderstanding or a distort of what LL said, and your analysis is based on that misunderstanding.
Why you are so itchy to make a conclusion. It is because we have a lots affords, turtles?
At this point of time and share price, shorts should all take a vacation and celebrate.
Life is so boring?
Will come back next Monday for selected reading.
Hi pal,
I know what you are going to say before you open your mouth! You are better at copying and pasting, so it's better for you just stick to that.
Hey I am poor at math, though I taught at universities very complex engineering courses. Please help to review the following copy and paste obtained from a quick googling:
"Human brains, she has learned, have 86 billion neurons, the basic unit that processes information. Mice have 71 million. And elephants have a whopping 257 billion—although relatively few are in the region of the brain associated with intelligence."
source: http://www.wsj.com/articles/new-technique-offers-faster-more-accurate-way-to-count-brain-cells-1412965403
then after searching of mouse lifespan, you get
"African pygmy mouse: 2 years"
from https://www.google.com/?gfe_rd=cr&ei=YOCqVrbNGKiC8QeprJ74CQ&gws_rd=ssl,cr&fg=1#q=mouse+lifespan
From the immense virtual world, after digging you may be luck enough to find some mice may live one hundred years while some humans may just live a couple of years.
So at end, you are always right.
Sorry Mev, I don't have time and capacity to do any real analysis. Shorts have done all that for me so I excuse my laziness.
AVII, give us a clear answer, won't you?
I have to admit no time to read all posts, just seeing AVII shown up again, and picked a couple of his.
Bye
Mev, appreciated your posts which are well written in essence thought may not be in term of English rules.
But, I don't agree with your conclusion about NW regarding future financing. It's a commercial world, anything could happen; as a matter of fact, the least likely possibility may be the most likely possibility. NW could be next financier again as long as 1) NDA is not breached and 2) LP's control stake is not challenged.
After all, LP and NW's interests are aligned though not in the same proportion. For LP it is dead and alive, or NW it is a peanut, though a significant one.
I also agreed with you on that most posters are non contributors which are fine for me. But I don't waste my time in any message board full of "little" guys, mostly for a few pennies gain in either way long or short, let alone those assigned to post in message board by hedge funds, who can be readily identified from the very beginning.
While I am bitter some times, I am happier since I have averaged down my huge holding significantly lower.
I have bought almost every day since the price hit around $0.7. Now I would resume my observer status: reading selected posts while posting spontaneously.
But, I do appreciate all those longs who have spent their invaluable time to rebuke all the naysayers!
God bless and bye now.
Beartrap: That is just my speculation, and no one knows for sure what has been happening.
That said, remember the reason for the trial expansion announced Aug 2015 is to further derisk so that a difference of 4 month PFS, instead of the initial 6 months can be detected statistically.
As a result, they increased patient enrollment a bit while significantly increasing the event counts for both PFS and OS analyses.
Apparently, to be able to detect 4 month PFS difference alone doesn't necessitate any increase in OS event counts, let alone increasing that number so drastically (from 72 to 233).
So, the new protocol after trial size expansion must have taken into account OS as a further derisk factor, meaning ss difference in OS can be detected, which can either support PFS for confirmation to AA or a outright full approval if both PFS and OS reach targeted thresholds.
Now assuming the company was informed there is more than 6 months PFS detected in the first interim analysis, really the targeted full enrollment of 248 patients in essence would not be imperative.
With just less than 248 patients enrolled and data on hand from 1st interim analysis, the company can pursue various fronts by voluntarily announcing partial half for additional patient screening with regulatory organs.
AA, rolling BLA submissions, enabling a change of the protocol to make a significant subtype to be analyzed alone and/or with the whole patient population, etc.
I don't know what has really happened, but there have been numerous cases the trials were stopped for efficacy with less than targeted patient numbers.
This is my last post today and good luck!
Thanks Turtle.
Accidentally, my mom died of stomach cancer too in 2006. After her diagnosis, surgeon removed her whole stomach. After that she received no radiation therapy nor chemotherapy because her body was too weak to take either of the usual two treatments.
The only treatment she had is some kind of bio-therapeutic treatment, which was actually a very inferior one. Nurse drawn her own blood and culture it in lab for some kind of enhancement. Then, put it back into her body.
She was a true fighter, never ever giving up in her life. She had about 2.5 years of quality life until her cancer spread all over her body, in liver, bone, etc. She told me every time when she received her own enhanced blood that she felt strength again. Then, after a while she would feel very weak, then a new treatment cycle began.
She died three years after her diagnosis.
I always hope she could have had a better treatment. That is part of the reason, an important part that I am very enthusiasm in biotherapeutic treatment, including cancer vaccine treatments.
Some basic facts worthy of repeating:
According to the existing protocol of DCVax-L P3 trial, the 1st interim, 2nd interim and the final event counts for primary PFS endpoint evaluations are 149, 198 and 248 respectively. The OS as secondary endpoint will also be evaluated and the final event counts for OS evaluation is 233.
Remember before the announcement of the trial expansion in Aug 2014, the final PFS event count is 110 while the final OS event count is only 72.
At least 66 events (PFS or PFS+OS) has been occurred before Dec 2013.[A speculation is before 66 events happened, around 150 to 210 patients had been enrolled]
[One speculation, not a fact is that]The protocol after expansion may have taken into account the statistical power for efficacy analysis for OS while [it is a fact again] the targeted PFS difference between the treatment arm and control arm is reduced from 6 months to 4 month.
Since the partial halt for additional patient candidate screening announced last July, approximately 12 months have passed by.
So, my guess is that the 1st and 2rd PFS event counts have been reached, and it is also possible that the final PFS event count may also have been reached.
IMHO, what happened around the partial halt announced last July is that the 1st PFS event counts were reached, the 1st interim analysis was conducted by DMC and the company received the recommendation from DMC.
I guess that the difference of PFS between the two arms may be more than 6 months, so the company might determine to temporarily stop screening for more patients since it might have enough patients for the statistical analysis of both PFS and OS endpoints; the company then might pursue an AA passageway or/and other passageways. Behind the scene, regulatory discussions, negotiations, submissions, FDA comments/hints, etc., have been going on back and forth. Nobody knows what is going on, but definitely something is going on and at some point, something has to be given, or the "issue" will be resolved.
There are numerous possibilities; just nobody knows what is really going to play out. Having speculations are great, but please stick to the facts we know.
See this is exactly the reason I have prohibited myself to participating in such waste of time debate, but I will try once:
You seem to be a person with some knowledge and not-robot-control nonsense perma bear and have some common sense so I don't really understand your reply, which is contradictory to what I have perceived of you.
What the company has done is common for any biotech company encountering such a situation! Why suddenly your seemingly rich biotech and FDA regulatory experience have disappeared?
Why the company has not declared and has still been quiet? Have you really asked that?
Because at this point of time, the company has not ascertained the trial is an outright success from the perspectives of both the company itself and FDA (including other regulatory agencies). Is that simple.
If you have been in any professional practice, you would know it's better be safe than sorry.
No reply anymore. Thanks.
An exception from me in reply:
Assuming your wife/husband is just diagnosed with GBM, and doc recommends try of DCVax-L;
The company developing DCVax-L, after observing unusually low evening rate of all patients in the trial as a whole, has voluntarily stopped enrolling any new patient candidates some ten months ago because it doesn't want to enroll any patients into the control arm as it is highly likely DCVax-L works;
Yes, it could also turn out that there might be no ss difference between the control and treatment arms (or early and late DCVax-L receiving patients) but the fact is "any patient enrolled in the trial lives longer, much longer than anticipated. This observation is based on updated 20 months or so anticipated median OS for this deadly indication. So to call it unusual, the median OS for the entire trial must be well over 25 months or even higher.
So do you think the company will risk being sued later by you, let alone it is unethical for the company, for knowingly putting your wife/husband with risks being put into the control arm to receive inferior treatment?
Do you think it is a right thing for the company to do to "temporarily" halt patient enrollment so it can wait to see if the unusual evening rate is indeed due to efficacy of DCVax-L before the temporary halt gets lifted for screening, or due to efficacy evidence, or something else ascertain?
What the company can say during this period of time! Can the company tell the general public the true reason for the halt (as stated above)? If the company did, would any patient in the trial have the right to know what kind of treatments they have had? If some patients find out they are initially in the control arm or still in the control arm, do they have the right to drop out the trial knowing they were or have been in the control arm (inferior arm) immediately so they can seek other trials or demand immediate access to DCVax-L?
Can you imagine what a mess that will entail? If the company did so, the trial will be severely compromised!
Said too much already, and I shall stop. Even with my big stake in the company, I still don't have enough time to participate in this message board. So my suspicion of those frequent posters, particularly those with no shares or claim to have a "core" shares.
How many events have been reached are unknown to the general public or even LP because the company may have long determined via DMC to see the final results, i.e., let the accruals (OS events) reach a certain number and forget the interim looks "in a certain degree" by focusing on OS analysis at the end.
The reason could be either of the two: 1) not ss PFS or ss enough PFS due to pseudopregressors but unusually low numbers of OS events; and 2) ss PFS plus the same unusually low numbers of OS events.
In either of the cases, it is unethical to continue with recruiting new patients, thus temporary half of additional patient candidates.
So IMHO, it is unlikely the "halt" will be lifted regardless the trial is deemed a success or not.
The key here for the trial is to see how truly the L is effective quantitatively as much as possible.
Because of all above, the company has to be quiet as long as it will take to reach that magic numbers of OS events followed by looking at the data and making conclusions by DMC.
The question is how this enough-is-enough scenario is going to play out. In the meantime, investors cannot do anything but wait, so is the company.
I believe that the hypothesis above is a sketch of what has been happening with the trial. Of course, usual and unusual regulatory negotiations, discussions, etc., have been ongoing since the halt.
In the end, I believe we will have some kind of approval regarding L and/or D in this year.
GL to patients and all!