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I thought I would post this in relation to the ambulance chasers and a post from YMB that stated they are going to sue
Good luck trying to prove intent because you bought stock on a secondary market (not ipo) and the burden of proof is significantly higher. You will have no case. But if you had taken entry level accounting regulation you would know the difference between the different SEC acts (1933 and 1934) and the differences of burden of proof when purchasing stock on the open market (secondary) as opposed to primary (ipo). Sue all day long you have no proof, the ambulance chasers failed last time for the same reason. Ask yourself this did the ambulance chasers tried to sue NWBO last year? What was the outcome? Answer they tried last year, and they failed because they had no case (meaning they could not pass the burden of proof). Case closed
That's direct criteria
They are going to issue a PR today as she stated on the phone as indicated on the Reuters post earlier today
Yup, they have the support. I don't understand why there has been a lid on them recently, maybe good maybe bad. Tough day.
Last time we had a tough day like this I bought more and was rewarded the following day. I hope that is the case with today (I have not bought any additional shares today)
I would appreciate an update on how things are working well, how things are not working well, and plans moving forward (with a response to this update pertaining to German temporary halt of trial)
I saw one article today reference a halting of "CVAX" that is how bad the media is in some situations. No fact checking, no editing, free for all.
I certainly hope so. I am not selling, but I am also not buying anymore until we get some news.
I agree their hand was clearly forced with a negative spin. Forcing a PR on a Friday afternoon. I am not selling my shares today. I am not pleased.
Correct
Why not just explain? I both love and hate that response. I love that we will get a PR, I hate that we have not received a PR yet and that it will be late on a friday.
Please confirm link or third party site to confirm accuracy of that claim.
I received a response from my email earlier to the EU but I don't think they are answering the question
Date & Time Logged: 21/08/2015 15:42:46
Application / Component: Eudra CT (Public)
Title of Call: EudraCT Number: 2011-001977-13
Update:
An error has been identified in the software used to load summaries of results into the EU Clinical Trial Register. The problem may affect a subset of results which have been processed outside of the system and reloaded to it. As a consequence, the summary results of clinical trials which have been entered into EudraCT and made public in the EU CTR have been removed from the public domain while they are reviewed and before being returned to the public view. In addition the access for sponsors to enter results or edit existing results has been blocked (and no new accounts are being issued) whilst the underlying software error that gave rise to the problem is resolved. As a consequence if you search for results, you will see the text “Trial results: Removed from public view” in the clinical trial summary. This incident does not affect the “Paediatric studies in scope of Art45 of the Paediatric Regulation”.
We will notify via email once this is fixed.
So after pouring over the EU website we can say that the temporary halt is not the following;
Prematurely ended
Prohibited by CA
Suspended by CA
Not Authorized
We can say that the trial is Temporarily Halted.
This information can be found by clicking advanced search on the link
https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-001977-13/DE
and sorting through the possible Trial Status's
So let's rule out some negative outcomes shall we.
To be correct Woodford does not own 100 million shares. He has invested around $100 million dollars.
CLDX is down more than 50% in less time than we are down 30-40%. Their accelerate approval was shot down and they had to resize their trial. Sounds like what we had to do last year.
Hi EU Clinical Trail Representative,
I am writing to inquire about the clinical trial EudraCT Number: 2011-001977-13. On your website the trial is listed as temporarily halted. What exactly does temporarily halted mean? When was the trial temporarily halted? How long does a temporary halt last?
Thank you very much for your time and your consideration.
I wrote an email to NWBO to provide clarity, for what it's worth.
Management should issue a press release providing an update on status or add clarity to a clearly material matter.
Management speak up
I have been around for years. I understand that often presentation are not groundbreaking and for the most part just rehashing data that is already out there. What is different about this time, is the presentation will be in the UK right about the time that additional financing is needed (now), we may also get some updates about UK activities.
I am not pumping the presentation, I honestly do not belief that Woodford has not prepared for this part of his investment in NWBO given that his investment horizon is timed in years not days. I don't think he would drop roughly $100 mil into the company thinking once this money is utilized on the trial they are on their own to go bankrupt.
That is pretty much the short argument again....
FDA just slammed CLDX on their OS primary outcome.
The data for Phase 1 is maturing, we will see an update. The last time we saw an update the data was positive.
Tell me again how the data is doomed to fail? This is a biotech company that is based on the data. Almost every biotech small clinical stage biotech company needs cash, we are no different.
I don't enjoy the current downward trend, but then again I didn't enjoy last October or last May (after the AF show) either, but look at the price now compared to last October.
I weathered those storms and I hold a profitable position even at today's price. I anticipate when this current storm ends we will again have blueskies.
Did you see what I did there?
How do you know that there is no progress on the numerous catalysts? Do you have non public information?
You have no clue about progress relating to the numerous catalysts that they are working on.
You do know that we will have an update at least on Sept 16-17th. Maybe before, maybe not.
They have not stated anywhere that we will PR once a month or once every two months.
If you think the data in the trial is not progressing/maturing, well then there is nothing I can do for you.
Your true colors are shining bright once again bluesky. It has been interesting watch you change from antagonist to promoter now back to antagonist.
If the FDA stated that OS in small trials is open to flukes then we should be better suited with PFS as our primary and OS as secondary as PFS is apparently less prone to flukes. The trial size was also an issue relative to the fluke aspect. So if you increase the size you reduce the probability of a fluke conclusion.
Positives to take away
We already increased the size of our trial (compared to our prior size, we have reduced the possibility of a fluke conclusion)
We have PFS as a primary outcome (FDA apparently views PFS as valid or in the case of small trials more superior to OS)
We have OS as a secondary outcome (OS is still an important outcome to evaluate/test)
That would require a great deal of explanation to compare apples to apples (CLDX to NWBO). There are slight differences and they are targeting different things (although both for GBM). My limited understanding is that CLDX has a particular group that it performs well with therefore that group is the basis of their criteria for their trials. Ours was powered for the same 6 month pfs but with the added patients we will achieve our target with only 4 pfs improvement. Many more points to compare and little time, CPA exam next week (passed regulation last month) wedding in October.
Others on the board will be able to provide a comparison of trial size before and after enlargement for both CLDX and NWBO and what that enlargement means, with context.
Yup, wait can you hear that? It's another basher argument debunked/rebuked. Heyooooo
I remember when they used to argue that CLDX would get to market before we would. That does not look like it's even remotely possible now.
That was not discovered on this board, Linda described the possibility of expanding the trial in one of her presentations, was the first time there was notification of the possibility. Guess who else just had to expand their trial?........CLDX
FDA apparently claimed that There can be issues with OS as the primary target in small trials, as there is possibility of distorted outcomes. Hmmmmm still think we are behind CLDX's trial?
If CLDX is not going to get fast tracked, who else is closer to the finish line? Answer we are
Who has a product that is broader in scope than CLDX? Answer we do
Hmmmmm something to think about
I have not sold a single share either. I bought additional shares yesterday @ $9.47.
I wish that is the case. I'm getting to the point of being tired of this downdraft. 17 days so far since MACD signaled a sell. 18 was the longest so far YTD, but during that stretch the price only dropped $2 not $3. I stand by the $9.50 support zone, I bought another 50 shares today at $9.47. Here's to 17+ days of gains.
Also the chart has tested $9.44 but has yet to close below that price.
They don't have to wait until September. All people are saying is that there is a planned event in September, and at that planned event they will make a presentation and be included in a round table/panel discussion.
In the mean time I will occupy my time with studying for the CPA (just passed regulation) and day dreaming of waking up to a positive PR with an opening price that is in excess of my expectations......until then.
To provide context that has happened before (twice last year, German news and direct updates) with NWBO.
Even though I bought more call options today I can afford to lose the money. I caution overextending risk, I would not recommend risking more than you can afford to lose. As much as I'd like to think otherwise this is a very risky investment.
I bought 6 sept 2015 $10 calls, not a lot of money.
I think we have not gone lower than the previous MACD sell signal period low of $9.44. Despite the flash crash and numerous attempts to drop the price we have yet to close lower than $9.44. We have been in the MACD sell signal for roughly 14 days. The longest MACD sell signal YTD has been 18 days and a $2 drop. We are at 14 days and a $3 drop. Yet if this turns or remains unchanged before the next leg up, then the trend of high highs and high lows will remain in tact. I compared XBI to NWBO today, and it appears lock and step with our chart. Also our performance YTD is up roughly 80-90%. I bought more options today if that is any consolation to you. I'd like to see the MACD converge soon and signal buy. I'd like some news, data, positive financing, etc. I am not selling anytime soon. My eyes are focused on the September meeting, which happens to coincide with the FED's meeting in March. With China devaluing their currency this week, some say that will cause the fed to postpone the rate increase planned for September, we'll have to wait and see.
NWBO is in a unique position where they are damned if they do (promote) and damned if they don't (promote).
If they discuss open label data they may have a blogger call a doctor who happens to work at one of the locations of the trial but is not personally involved with the trial (in fact works on competing trials) to denounce discussing open label data.
If they don't discuss they trials no one knows about them to participate in them.
Good old catch 22
Correction "event"
Turtle the September ever is already listed under "upcoming events" it's a presentation in the UK on September 16-17th.
The big fish probably have reviewed the detailed accounting more than we have. Nwbo is obligated in certain situations to provide shareholders will the "books". There are criteria that must be met before you can have the right to look at the books as well as the purpose of looking at the books must fit certain criteria as well. Generally the books will be available at the company HQ for shareholders on record. So unless you are a shareholder in record, are physically at HQ, and meet the "purpose" criteria, then you won't have as much detail as someone who does meet those requirement. I am of the opinion that Woodford or woodford's team has done this before spending a $100 million on NWBO, although I have no physical proof. What do you think?
If the next dilution was for $100 million we probably would not need further dilution for a year (or upon L approval, if that happens before 1 year). My thoughts about a $100 million capital raise would actually be bullish.
I don't think it will be for $100 million, but I could be wrong
As a point of context please note below;
Woodfords first financing occurred at $5.79
Woodfords second financing occurred at $7.40
That represents a 28% increase in the financing prices from 1st round to 2nd round.
Question if woodford financed again at another 28% increase what price would that be?
Answer = $9.47
If we get to $9.47 I will buy more, and for more reasons than that (technical support levels). But I just thought about that and wanted to share that with the board
I probably won't be able to sleep on September 15th and September 16th, as we have presentations on the 16th and 17th.
What do you think will happen if we raise $100 million?
AF was also very pro CLDX. His record this year on NWBO and CLDX is like the chart of NWBO overlaid on TST. Check it out for your selves, or look at NWBO overlaid on CLDX. He was wrong on both sides of NWBO and CLDX, ouch for his credibility.
These downward movements are not pleasant but they are part of the ebb & flow. I remind myself two things 1. my cost basis of all my shares is profitable and 2. when the next upward movement occurs the current unpleasant mood will be replaced with additional rewards.
They will manipulate, that is what they do. I thought this part was refreshing,
For the six months ended June 30, 2015, the Company made net disbursements to Cognate of approximately $21.3 million (with invoices generally paid all in cash rather than half in cash and half in stock), including charges relating to manufacturing for both the Phase III and Phase I/II clinical trials, ongoing product and process development, and expansion of several Company programs under these service agreements. With the substantial expansion of recruitment in the Phase III DCVax-L trial during this period, patient volume has exceeded the maximum amount contracted for, and as a result the disbursements have included excess production costs. In addition, the disbursements have included preparatory work for multiple different Phase II clinical trials, which the Company anticipates launching during the second half of this year, as well as development work connected with new intellectual property and certain regulatory requirements. The disbursements have also included substantial one-time services related to manufacturing expansion in Europe.
Following the market. From Technicals, Short term stochastic is displaying a buy signal. Mid term MACD is displaying sell signal, but the signal is getting very old (time is almost up on the sell signal, at that point it will be a buy signal)
Fundamentals have not changed at all. We should be receiving and update on the quarterly financials At the end of the week or next if they extend their filing requirement which they are able to do.
Shorts will argue that NWBO is lax in their filing requirements. NWBO can extend their filing requirements for a certain period of time.
Just as every taxpayer in the US is eligible for an automatic 6 month extension to file their taxes, so are companies that are required to submit financial statements to the SEC. In the case of SEC extensions they are not 6 months, it's a matter of days/weeks not months.
That doesn't change the fact that they do not prepare the financial statements nor does the SEC attest to the accuracy of the financial statements of any publicly traded company. That is not the function of the SEC.
Sec doesn't prepare the financial statements nor does the sec attest to their accuracy, that's what the accountants/auditors are for. The sec enforces. Big difference, RK.
correction "prize"
Stop the presses, the whole trial is a complete farce....iclight what would I do without you? Effective Monday morning, pre market, I am not only going to sell all my shares but I am also going to short every last share I can find available.
I mean really, how can they have that inclusion criteria included in the trial so that the patients actually receive a minimum amount of (4) doses. They are clearly cherry picking, for sure.
Icilight I am going to nominate you for a Nobel price in journalistic excellence for uncovering such a brilliant point that completely refutes the whole study.
Please forward your information on to MDA Anderson and every other clinic that is participating in the trial.
Ohhh wait........