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I would rather
vacuum my porsche
or fertilize my lawn
Rather flirt with 20s something beauties
or feed more families in need
Waste no time to anything not straight, not conscience
I would rather sail the last voyage
to the sea before first winter snow
or sip a tea on an aged wooden deck
Rather no waste no time to anything not straight,
Not conscience!
Want to have fun to entertain yourself with
A virtual lady resurfaces with new script with old task
No more than 5% from someone endlessly remains sideline
So advised with no interest of a company, GMAB!
A harbinger of the entertaining king who might reemerge
With entrust of the shorts
To invest or not
No more a question!
Cause' each 'useless' share will end up
in Woody's hand
or mine
No more time to waste
For an old entertaining lady
cause' our days are young and full of sunshine!
Nobody knows what is the reason for this temporary screening halt. Nobody!
This halt was first spotted for German part of trial. That's it. As a matter of fact, the halt is universal in screening halt.
Nobody knows either what specific regulatory authorities the company is now dealing with with this issue.
This is my last post for today! I normally hate this message board because of its full of FUD, redundant stuff and useless trivial, but for what reason I started post a bit recently.
I would rather go golfing a bit more. Good luck Stillwell888.
BTW, I like your triple eights, and that might be the stock price I am hoping for!
You may have reading comprehension problem.
It is unlikely. Even if it were true, why those patients in the pipeline already have been directed to other trials and have not randomized into the existing L trial?
Safety issue? again. Are you nuts?
There are numerous examples of p4 confirmation trials. Just google it you will see some at least. Basically, when a company gets AA or the like, it has to run a successful p4 confirmation trial in order to get full approval. Nonetheless, since the company can market and sell the approved product (AA), it is usually the case that most of such companies would be reluctant to start and complete a p4 confirmation trial required for full approval. One other problem is that because the product is an approved commercial product, it is difficult for the company to get enrolment done. Of course there are about 15% approved products statistically get pulled out from market after a failed p4 trial.
So it seems that FDA nowadays is more inclined to allow a trail to serve the purpose of both AA and confirmation, kind of combining "two trials" into one integrated trial.
That's why a company has to be very careful not to compromise in anyway of the existing pivotal trial in the event of a stop for efficacy recommendation from DMC based on IA. So there are certainly uncertainties, secrecy and confusions coming with it.
If you have time to go through this example: http://www.cathlabdigest.com/articles/FAME-II-Stopped-Enrollment-Early-More-Events-Medical-Arm-What-Does-It-Mean-PCI
you would understand what has been really happening behind the scene that is [my speculation of course but with some logic and supports]I reaffirm that DMC has recommend the P3 DCVax-L trial stopped for efficacy so the enrolment of the patients should be stopped due to ethics reason;
Northwest Biotherapeutics Inc. has thus "only" elected to "temporarily stop new patient screening" pending FDA blessing (AA) with materials asked by and submitted to FDA.
Only after the blessing of FDA, can the company announce stop of enrolment, and continue [has been continuing] to monitoring the existing patients to the final events [it may be a full approval or the company may be asked to do a P4 confirmation study].
There are also other possibilities as I have said before but definitely not anything to do with safety.
Just a patient story of a former teacher who was enrolled early this year in the current P3 DCVax-L trial. The link is below:
https://www.tapinto.net/towns/morristown/categories/news/articles/under-care-of-morristown-doctor-veteran-teacher
I have no problems on whoever who goes long or short, provides whatever opinions on the vaccine, but I do feel indignation on those who have intentionally distorted fact and spread FUD. Because by doing that, you have driven potential patients who may be benefited from the vaccine away from the trial, which IMHO is equivalent to genocide.
For whatever kinds of work, a bit of ethics and conscience is required!
Just want to say, hi to everybody, and have a good weekend! [Including TOB if you are not deleting this message?]
Ready,
You are complete right but only that the DMC would decide to have a look, which depends on not the information arm data but "the aggregated data of the P3 trial, which are unblinded" but can certainly suggest of "exceptionally good" results.
Things like that rarely happen, but when it comes it is 100% like that of today's story about lower the blood pressure as low as 120 for the senior with high blood pressure for health benefits in a landmark trial call Sprint, which is stopped very earlier. The article appears in NY Times:
http://www.nytimes.com/2015/09/12/health/blood-pressure-study.html?hp&action=click&pgtype=Homepage&module=first-column-region®ion=top-news&WT.nav=top-news&_r=0
You have stretched too much but your efforts are appreciated. Agreed the stubbornly fixed number of 300 and the final data collection day of September 2015 appeared in the clinical trial site might mean something although the site is famous for its unreliability: while all other trivial has been updated regularly , why not the total enrolment number and the final data collection day if there were some changes?
As far as the most positive scenario is concerned, DMC by seeing the unexpectedly good data (unblinded)can decided to have a look (interim analysis) before full enrolment. No rules have prohibited that. And if the results confirm, it can recommend stop and the company can file AA application to FDA if the results are significant good enough (for instance, more than 6 months or more PFS advantage over standard of care compared to the target 4 months). Of course, before the filing, there must first have some consultation with FDA for direction.
If FDA not buy it, the company may just issue a release saying the temporary screen halt has been lifted as the 1st interim analysis has been conducted, and the trial will continue according to the protocol.
First, I 100% agree with your observations, but sometimes the constant obsession with this guy had made me conclude the learning curve is really long and slow for some people here who have had real stacks in this company.
I had friends and myself included who had been approached by hedge funds for salaried work for them. I had no interests since my work was much meaningful than the one offered. ONe of my friends (message board friends with personal email contacts) took the job for $150,000/a many years ago for a notorious hedge fund in NY.
By now, people must have understood P, and IVII are merely two salaried employees of certain hedge funds which are interested in NWBO's share price.
In several occasions in their posts, they almost admitted that, although not directly and it is against their work specification.
Normally, people were initially bullish on a certain stock and had published some interesting articles in SA, etc. After a while they might be approached by or they themselves might apply to certain hedge funds for jobs.
Such things happen in daily basis! I guess the opposite happens as well.
People shall not trust anyone long or short who have seemingly unlimited time spent in a particular stock, unless they have no real work to do.
Hope this helps!
A successor?
Where have you been while he posts day and night in this board?
Coincident?
He be best left alone for natural correction if God is willing to help!
No direct response is the best way to help him!
"out of box' thinking? He is not close to that or he is much more than that dependent on convenience.
For instance, in his post citing impossibility for interim analysis to be conducted if enrolment is not complete, the document he cited is an FDA discussion I remembered clearly in the time when I have involved in a couple of Non Small Cell Lung Cancer companies as an investor, and is titled "Clinical Trial Endpoints for the Approval of Non Small
Cell Lung Cancer Drugs and Biologics Guidance for Industry."
1) Clearly it is specific to Non Small Cell Lung Cancer companies [it may not apply to other cancers, although it might have reference value]; and
2) It emphasizes "the observed magnitude of effect should be substantial and statistically robust," and " In addition, a statistically significant difference in PFS that is small in magnitude may not be deemed clinically meaningful." [the small here means 1~2 months PFS with significant p].
So a company which uses PFS as primary endpoint for Non Small Cell Lung Cancer indication can definitely have interim analysis before full enrolment and DMC can definitely recommend trial be stopped due to efficacy as long as PFS advantage is significant [like 3~ 4 months or more] with significant p value and the treatment is of course safe.
For those who are interested, the link of the document is below:
http://www.fda.gov/downloads/Drugs/.../Guidances/UCM259421.pdf
Yes senti. Not a single person can cause a significant price drop unless there is collaboration behind scene, and not every such attack can make share price drop. It all depends on many things. The recent one is just a very good timing, when people were panic, they just sold first and asked questions later.
As far as my trading of vix is concerned, I have tried to time for a market correction since May by longing vix option every month although I also buying put. During this process, I have had two big wins (the recent one and one associated with Greek fiasco) but a little bit bigger loss after Greek fiasco (I got too greedy). Overall I collected about $60,000 profit net.
See I have been a bear in general since May, and I have sold many other stocks partially and completely, but I have not sold any single share of NWBO. I am so stubborn in longing NWBO. Now I only have NWBO and VVUS (I added significant shares recently) with tons of cash ready to start new positions. Definitely, I will add more of NWBO in case...
To be honest, the recent big drop of share price is not due to general market trend or a post or two in which the temporary screen halt are mentioned, but due to concerted and "good timing" of shorts, speared headed by AF in a blogger appeared in the street the exact day of market panic (vix shooted to multi-year high that day. A side note because of that I made about $50,000 dollars by buying vix option a week earlier).
The exact purpose of our famous the "extremely long" turned into the "extremely short" (or should I say someone with no position according to his saying but behaving super short in nature), is that by spreading FUD, self created or coming from others, in this case it came from Senti, who got it from IV.
The simple matter of fact is always that no one can control the market, but some ones certainly can time the better time of "attacks" with known information. This one took a few to a whole week for the short to ultimately came out.
Shorts won this battle by permanently damaging the share price, but rest assure, it will come up back again as I don't think there is any safety concern, which the street (not that infamous the Street) has been led to believe more or less by countless "class action lawsuits", reflected in share price.
I believe the chance of temporary screening halt due to safety is remote, and the trial will ultimately meet its primary end point and second endpoint. As a result, I have added to my existing huge piles of shares and options recently by options (which I have mentioned here some of the buying recently.)
Again, I have been amazed and continually been amazed of seeing people who still respond to the now should be all known main FUD spreader, who have always have a couple or a few support characters in conversation.
As always sorry for no spelling check, etc. I have tried to think is this post off topic or is this post of some personal attack. I don't come with a yes answer. So can you guys not delete it! Or should I care?
Have you actually read the safety case I provided you twice? Your comprehension of basic fact is a question.
Simply put,if nwbo had a safety issue, PATIENTS IN THE TRIAL WOULD HAVE NOT BE TREATED WITH DCVAX-L VACCINE.
AS A MATTER OF FACT, THEY ARE CONTINUALLY TREATED ACCORDING TO PROTOCOL!
Man, please don't let me depressed about our humans nature!
Re my position at the time: Too busy so I will simply outline what I am thinking and what I have done:
Still remember one DNDN drama in one morning reading press release regarding its confirmation P3 trial, which simply said it had med its primary endpoint, etc., but the share price suddenly dropped from twenties to a single digit. I could not believe my eye and thinking should I sold or buy more, but had not time to figure it out as I was a speaker in a conference in a few minutes.
Coming back opened computer again, the price was already back and went much higher.
Such things could happen here as I believe NWBO is in the cusp of something big happening, so just be careful!
There are other numerous tricks shorts can resort to in case of something big is going to happen, but I am not going to detail here.
Bottomline, re my position is that I believe something big and good is going to happen, although the general market is still in a major downturn, I will not want to miss this long waited time by selling any of my big pile of shares, options. Instead I have added 20 '17 target $10 options last week at $2.15 a piece, and 15 '17 target $7 option contracts yesterday at $3 a piece while I have set purchase orders of options and shares at much lower price in case a major short attack happens and the price is walked down significantly and temporarily so that I can catch some real cheap orders.
I am a retail investor who already holds a very significant position. It is not easy for me to decide to add more, but I will if share price becomes even more attractive.
No check of spelling, so sorry for any error and inconvenience!
BTW, my last post for today is to urge people not to reply to those posters whose existence is not to discuss anything to do with NWBO but...
In short, if there were ever a safety issue in the current P3 L trial, the FDA would have placed a hold on the trial, and the company would have to stop not only new screening of patients, but also treating any existing patients in the trial.
In the meantime, the sponsor will investigate what is the cause of the safety issue. If the investigation concludes the safety issue has nothing to do with DCVax-L vaccine, the results will submit to FDA. If FDA agrees, the trial may be resumed; on the other hand, if the investigation concludes the safety issue does have something to do with the vaccine, the trial may be over for ever!
I hope I will never need to reply to you for the same reason.
Some of your statement below
"
I clearly meant that a patient most probably died in the Ph III trial, recently (perhaps in July), and it spurred an investigation. I think it may have occurred in Germany as they seemed the quickest to respond by issuing a temporary halt on their CT version.
There are very few reasons why a temporary halt occurs, and even fewer as to why it occurs in pivotal trials. A temporary halt never occurs to file AA or enter dialogue with regulators as to whether or not it is advisable to halt the study and begin that process. The trial simply remains ongoing or fully and permanently halts for that. FDA will give general advice in these circumstances but will refuse to even examine any efficacy data so that if they have to make a later decision they can do so in an unbiased manner.
A temporary halt of a pivotal trial, especially if this far along in events and enrollment, is almost always going to be due to a safety concern. Initiated by DMC, who will submit all data on the patient who died (probably of encephalitis in this case) along with all safety data from the trial. That takes some time to assemble. It's not a clinical hold, yet, but the steps before one might be issued. Yes, it's a real possibility here, but most likely regulators will examine data and declare the therapy safe to continue. When, you ask? Who knows? Probably they will submit the rest of data in another week or two and then receive a response within 3 months would be my guess."
I remember I took an exception to reply to your endless posts of your belief there is safety issue going on in P3 DCVax-L trial. I hate to see there are still posters reply to your not innocent FUD. So I am going to post it again below:
"
Dan88 Tuesday, 08/25/15 12:39:30 PM
Re: Pyrrhonian post# 39286
Post # of 39735
Just back from my long vacation and a quick trip to Southern China thereafter.
Seen so many posters have replied to your endless FUD, I am going to take this exception to reply to your post (no further replies shall be expected):
If it is due to safety issue, the company would not only stop screening patients, it would have to stop recruiting and treating any patients (existing and potential). See example below:
" Oncothyreon announces temporary suspension of Stimuvax clinical trials by Merck Serono
SEATTLE, March 23, 2010 /PRNewswire via COMTEX News Network/ -- ONCOTHYREON TO HOLD TELECONFERENCE AT 5:00 PM EDT
Oncothyreon Inc. (Nasdaq: ONTY) today announced that Merck Serono, a division of Merck KGaA of Darmstadt, Germany, and its U.S. affiliate, EMD Serono, Inc., have temporarily suspended the worldwide clinical development program for Stimuvax(R) (BLP25 liposomal vaccine). The suspension is the result of a suspected unexpected serious adverse reaction in a patient with multiple myeloma participating in an exploratory clinical trial. This decision was taken in alignment with the U.S. Food and Drug Administration's (FDA) clinical hold placed on the Investigational New Drug (IND) application for Stimuvax.
The suspension affects the Phase 3 clinical program for Stimuvax, including the START and INSPIRE trials in non-small cell lung cancer (NSCLC) and the STRIDE trial in breast cancer. Further recruitment of patients into all trials actively recruiting patients and ongoing treatment with Stimuvax in these trials are suspended.
"Patient safety is of paramount importance to Merck Serono and to Oncothyreon," said Robert L. Kirkman, M.D., President and CEO of Oncothyreon. "We understand that Merck Serono is working closely with the FDA, other regulatory agencies and the patient's physicians to evaluate the implications of this adverse reaction and to determine an appropriate course of action."
The exploratory trial in multiple myeloma is designed to investigate the mechanism of action of Stimuvax and the effect of cyclophosphamide on regulatory T cells, which may affect the response to the therapeutic vaccine. The adverse event occurred in a patient receiving a more intensive regimen of low-dose cyclophosphamide than is utilized in the Phase 3 program. The patient developed an encephalitis, or inflammation of the brain. No other events of this kind have been reported in other trials of Stimuvax to date.
Conference Call Information
Oncothyreon will host a conference call and webcast today at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time. To participate in the call by telephone, please dial 877-280-7291 (United States) or 707-287-9361 (International). In addition, the call is being webcast live and can be accessed on the "Events" page of the "News & Events" section of the Company's Web site at www.oncothyreon.com. An archive of the webcast will be available after completion of the discussion and will be posted on the Oncothyreon website.
About Stimuvax
Merck KGaA has an exclusive world-wide license from Oncothyreon for Stimuvax. Merck KGaA is investigating the use of Stimuvax(R) (BLP25 liposome vaccine) in the treatment of NSCLC. The vaccine was granted fast-track status in September 2004 by the FDA. Stimuvax is being developed in Europe by Merck KGaA and in the United States by its affiliate, EMD Serono Inc.
START is a multi-center, randomized, double-blind, placebo-controlled Phase 3 study that will evaluate patients with documented unresectable stage IIIA or IIIB NSCLC who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. The study will involve more than 1,300 patients in approximately 30 countries.
The INSPIRE study is a multi-national, Phase 3, double-blind, placebo-controlled, randomized clinical trial designed to evaluate the efficacy, safety and tolerability of Stimuvax in subjects suffering from unresectable, stage III NSCLC and demonstrating either stable disease or objective response following primary chemo-radiotherapy. The study will enroll approximately 420 unresectable, stage III NSCLC patients across China, Hong Kong, Korea, Singapore and Taiwan.
STRIDE is a randomized, double-blind, controlled, multi-center Phase III study designed to determine if Stimuvax(R) can extend progression free survival in patients treated with hormonal therapy who have inoperable, locally advanced, recurrent or metastatic breast cancer. Overall survival, quality of life, tumor response and safety will also be assessed in this study."
The link is here: http://ir.oncothyreon.com/releasedetail.cfm?releaseid=453976
I keep adding shares and options since this drop. Today I also add 20 2017 target $10 call contracts at $2.15 a piece.
I will continually urge people not to reply to your posts, since you are a person proven not trustworthy (moderator it's my genuine opinion, please not think it is a personal attack and name calling. Thank you).
Too busy, not time to post further, and life is beautiful, not intend to waste my time in thing like this."
And I summarize in my next post:
"
Dan88 Tuesday, 08/25/15 12:47:42 PM
Re: Dan88 post# 39308
Post # of 39735
BTW, I went through that whole process with your IV friend in 2011. All patients in the trials not only the one in which the safety issue occurred but all trials using the same vaccine called Stimuvax at the time were stopped of any further treatment with the vaccine.
Above is just additional information for those who are so busy to sort through the news I provided."
Hi Senti, pls see a reply I posted yesterday in Yahoo message board since my limit is three posts here and I had reached that when I saw your post.
Thanks duderaja. The next couple of weeks will be interesting in terms of share price movement.
As far as short-allied lawsuits are concerned, although it is laughable it may be in effect serve to our longs' interest to publicize our company which is in the cusp of a definite success to those people who can actually sort through the seeming negative news brought about by these "law suits."
If that is the case, the share price will have to rise significantly in the near future before good news is announced.
I want to use my last post as I am a paid subscriber in this board to say that the only thing I can come up now to explain the low share price now is of a conspiracy one which may be just an entertaining:
Since no other major funds have paid attention to the company except for those which have already had a major position, when news like this (always fuzzy or not transparent or straightforward due to its nature) broke out, not many funds really understand what it really means; on the other hand, the shorts funds have always thought in a biased way just as the long funds have always thought in an equally biased way in different direction, short funds have continually shorted shares they can have to subdue the price, hoping one day the company will go bankrupt, while the long funds already in major positions don't want to take a bit of more risk, decided to sit it out for a definite sign.
So there is still a depressed price.
The good thing if God willing, is that if that definite sign is out, both longs and short funds and the general public and lots of new funds will compete with ever dwindling share counts, and the price will go much much higher than if the price now were in the teens or twenties!
Just want to add: some people still ask why the halt for screening new patients? Some people have provided various reason.
Simply put, if AA is in the process, or if the company via CRO knows the results have med prespecified requirement, continually screening, recruiting and enrolling patients according to the protocol is simple unethical.
So I believe the existing patients, ie those already enrolled in the trial are continually being treated according to protocol while no new patients are screened and recruited, and any patients in the pipeline are not randomized, until consultation with FDA, etc. is complete with directive results!
It could be AA granted or continue with the trial.
But, some other possibility still exists between the above and a safety issue.
I believe this time what you say is truth to yourself and actually reflect what is your position: light yet tons of peripheral investigations, opinions and comments.
What happening is DMC's recommendation to the company via CRO halt for efficacy and what is going on is the consultation with FDA, etc, on whether an AA or outright approval is a possibility or whether the trial needs just continue, as the universal or trial-wide halt is now in effect, not only in Germany.
If there is safety concern or actual safety consequence, FDA will immediately place a hold and the company will stop treating patients enrolled in the trial, let alone screening, etc.until investigation into such an issue is complete.
The time for the first interim results and recommendation is just right, and the company has let us in the dark for so long a time; as the price is high, the company has not yet raised any new funds, ... all point to such a happening.
Now the only thing makes me think otherwise, or there must be other something (possibility) up in the air is that the market has not responded the way that an AA is in the process, otherwise the price must have been in the teens or twenties at least!
Either way, as long as safety issue is ruled out, holding or adding some may not be a bad idea!
Never check back my English in most of my board writing, so sorry for any errors or inconvenience!
Thanks Senti. From the beginning I was convinced it might be a halt due to AA consultation with FDA and other authorities in EU if the halt is not universal or at least HE if the halt is only for Germany.
Now thanks to your guys hard work and the possibility of AA just gets stronger.
Either way or maybe it just some adjustment of the trial which I have not seen at this time. I have determined as always to see the light, the approval of DCVac platform as an effective cancer treatment!
That day may just come earlier than most have expected!
How ironic, how funny, I like it.
BTW, I went through that whole process with your IV friend in 2011. All patients in the trials not only the one in which the safety issue occurred but all trials using the same vaccine called Stimuvax at the time were stopped of any further treatment with the vaccine.
Above is just additional information for those who are so busy to sort through the news I provided.
Just back from my long vacation and a quick trip to Southern China thereafter.
Seen so many posters have replied to your endless FUD, I am going to take this exception to reply to your post (no further replies shall be expected):
If it is due to safety issue, the company would not only stop screening patients, it would have to stop recruiting and treating any patients (existing and potential). See example below:
" Oncothyreon announces temporary suspension of Stimuvax clinical trials by Merck Serono
SEATTLE, March 23, 2010 /PRNewswire via COMTEX News Network/ -- ONCOTHYREON TO HOLD TELECONFERENCE AT 5:00 PM EDT
Oncothyreon Inc. (Nasdaq: ONTY) today announced that Merck Serono, a division of Merck KGaA of Darmstadt, Germany, and its U.S. affiliate, EMD Serono, Inc., have temporarily suspended the worldwide clinical development program for Stimuvax(R) (BLP25 liposomal vaccine). The suspension is the result of a suspected unexpected serious adverse reaction in a patient with multiple myeloma participating in an exploratory clinical trial. This decision was taken in alignment with the U.S. Food and Drug Administration's (FDA) clinical hold placed on the Investigational New Drug (IND) application for Stimuvax.
The suspension affects the Phase 3 clinical program for Stimuvax, including the START and INSPIRE trials in non-small cell lung cancer (NSCLC) and the STRIDE trial in breast cancer. Further recruitment of patients into all trials actively recruiting patients and ongoing treatment with Stimuvax in these trials are suspended.
"Patient safety is of paramount importance to Merck Serono and to Oncothyreon," said Robert L. Kirkman, M.D., President and CEO of Oncothyreon. "We understand that Merck Serono is working closely with the FDA, other regulatory agencies and the patient's physicians to evaluate the implications of this adverse reaction and to determine an appropriate course of action."
The exploratory trial in multiple myeloma is designed to investigate the mechanism of action of Stimuvax and the effect of cyclophosphamide on regulatory T cells, which may affect the response to the therapeutic vaccine. The adverse event occurred in a patient receiving a more intensive regimen of low-dose cyclophosphamide than is utilized in the Phase 3 program. The patient developed an encephalitis, or inflammation of the brain. No other events of this kind have been reported in other trials of Stimuvax to date.
Conference Call Information
Oncothyreon will host a conference call and webcast today at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time. To participate in the call by telephone, please dial 877-280-7291 (United States) or 707-287-9361 (International). In addition, the call is being webcast live and can be accessed on the "Events" page of the "News & Events" section of the Company's Web site at www.oncothyreon.com. An archive of the webcast will be available after completion of the discussion and will be posted on the Oncothyreon website.
About Stimuvax
Merck KGaA has an exclusive world-wide license from Oncothyreon for Stimuvax. Merck KGaA is investigating the use of Stimuvax(R) (BLP25 liposome vaccine) in the treatment of NSCLC. The vaccine was granted fast-track status in September 2004 by the FDA. Stimuvax is being developed in Europe by Merck KGaA and in the United States by its affiliate, EMD Serono Inc.
START is a multi-center, randomized, double-blind, placebo-controlled Phase 3 study that will evaluate patients with documented unresectable stage IIIA or IIIB NSCLC who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. The study will involve more than 1,300 patients in approximately 30 countries.
The INSPIRE study is a multi-national, Phase 3, double-blind, placebo-controlled, randomized clinical trial designed to evaluate the efficacy, safety and tolerability of Stimuvax in subjects suffering from unresectable, stage III NSCLC and demonstrating either stable disease or objective response following primary chemo-radiotherapy. The study will enroll approximately 420 unresectable, stage III NSCLC patients across China, Hong Kong, Korea, Singapore and Taiwan.
STRIDE is a randomized, double-blind, controlled, multi-center Phase III study designed to determine if Stimuvax(R) can extend progression free survival in patients treated with hormonal therapy who have inoperable, locally advanced, recurrent or metastatic breast cancer. Overall survival, quality of life, tumor response and safety will also be assessed in this study."
The link is here: http://ir.oncothyreon.com/releasedetail.cfm?releaseid=453976
I keep adding shares and options since this drop. Today I also add 20 2017 target $10 call contracts at $2.15 a piece.
I will continually urge people not to reply to your posts, since you are a person proven not trustworthy (moderator it's my genuine opinion, please not think it is a personal attack and name calling. Thank you).
Too busy, not time to post further, and life is beautiful, not intend to waste my time in thing like this.
Yes that would be a concern. My understanding is that any recommendation received by the company is a material news and the company must convey to the general public within 72 hours.
In my opinion, the window for that to happen is from now to late October, and the result would be more than 80% for a continue, and about 15% for stop for efficacy or about 5% for stop for safety concern, but I love a positive surprise!
In the meantime, I expect we will have some other positive news.
Thanks TC_Trader.
Hope shorts' last standing nerve collapse soon, either at $15 or $20.
Good day.
Does that surprise you? I bet yes it does. Keep your eye, yes just one, open wide. We will be in the territory NWBO deserves, which is just catching up with its peers.
I don't want give a specific number, and you should do a bit of DD if you are interested.
Now go delete this post, Mr. TOB.
You are right for most small biotech companies under normal circumstances, but it has shown this situation have no longer applied to NWBO.
Just review the last two financings from Neil Woodford. Each time we had a financing, the stock price moved higher due to the positive terms of the financings.
We all owe something to Neil Woodford. He is an amazing guy with a vision.
All in all, NWBO may not need any financing any more due to conversions, possible partnership deals, or even income from HE.
The hard and cold truth is still that NWBO's share price is still severely undervalued at $12.
Everything should be put under that perspective! BTW, if we keep going like this for a few more days, a squeeze has to happen!
It has puzzled me and sometimes made me angry seeing posters (long shareholders) guess what is really behind the price appreciation any time the price is going up. It seems they are trying to time the market at such a low price of $11.
Well, if you are long, and have done your DDs and believe either L or D or both L and D will be successful in developments to become blockbuster cancer treatments, why the shaky hands and minds of efforts guessing a price which is far less than its due price.
I said it before, and I am going to say it again. If JUNO can have around $6 billion market cap in such early development, why cannot we have the same MC?
That would give us around $80 a piece. At today's price of $11.39, it may be fun to have this or that speculation, but really, give me a break!
Wake me up when the price heats at least $30, where I will keep a watchful eye on it. Now it is summer vacation!
Fair enough, Evaluate that nobody would and should have that kind of information as you stated!
In biotech investing, only things matter are 1) does the company has a solid support financially? [My answer is yes. It is backed by Sir Neil Woodford, and others]; does the company's development is fundamentally sound and in competitive advantage [my answer is a yes, backed by all the information we have had today]; and does the company's market cap has been reflected fairly compared to its true market potential and that of its peer? [My answer is no, and it is well off at this point of time]
I don't care day to day up and down in price and from time to time throw a sword at someone who understandably swings trading. My thesis has had no change.
I have too many shares and call options, but I am ready to buy more call options if the price goes down; on the other hand, if the price continually goes up, I am okay with my decision of no action until the price reach certain high territory, for instance $30.
Not intended to reply on behalf of OTCPimp, but below is my answer:
The trump card might be stop for efficacy of L trial (why subject of ASCO subject had changed to excluding of L)in the near future, or
The trump card might be FDA's breakthrough designation for D, or
The trump card might be a big announcement of cooperation with a BP, or
The trump card might be a leak information about a buyout intent launched by a BP, or
The trump card might be completion of enrolment of L trial (about 15 sites have completed and now listed as "active not recruit patients" or simply "complete," or
The trump card might be the long awaiting HE price negotiation news, or
The trump card might be the completion of the long awaiting UK designation, or
The trump card might be a well-known Wall Street investor having invested significant amount of money in the company, or
The trump card might be simply unknown at this time!
I constantly think about the reason why I should sell a single share at this time before the share price is at least close to our nearest peer CLDX at a market cap of about 2.3 billion today, which will give us a share price of about $33.
Maybe you can give me some reason to consider!
Probably incurred after market close (after hours) at a price accommodating the day's price. Big guys do this all the time.
Please continue with your DD until we are in the fair price range of $39 ~ $81 compared to our peers.
BTW Pyrr, it seems you now have a better and prettier cover than what you used to have.
Place your hand on the Holy book, and say "I am not Pyrr."
Oh, I should have not asked that, with your drinks too much each night; what I can expect?
Why the title of the presentation at ASCO had been changed from including both D and L to only including D?
As I speculated in yahoo board (not post often now since I had tired of reading mostly useless posters some time ago. The same applies in this board), the events of 149 patients for the first interim analysis might have been reached just after the first time the title shown up in the public eye (thus the change of the title soon after).
are we waiting for DMC's recommendation now? !
If this is true, the price will continually climb for a couple of two more months until DMC comes up with a recommendation.
On the other hand, I also personally speculate that one or two Wall Street big names, either of investment firms or individual hedge fund/fund managers will be known to the public for taking a significant position besides UK's Woodford.
If either of these events happen, the price can easily go up to $20 and higher in a short period of time, excluding other major catalysts such as UK's final stage designation, HE price negotiation, D P2 launches, partnership deals with CI company...