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You need to check out how much Dendreon spent and you may be pleasantly surprised how much lower are NWBO's costs.
Bingo ! Fully agree. Long-awaited news very likely next week.
He's just a stooge working for the shorts. Not hard to figure out looking at the pattern of his posts.
Flipper and Senti, can you help me with my thinking? I'm trying to get a handle on where we stand.
Let's assume an interim review has occurred. A stop for futility or safety is ruled out because the trial and treatment is continuing. If the DMC's recommendation was for the trial to continue, does NWBO have a legal obligation to PR that? Even if there was no legal obligation, I'm not sure why they would not choose to update us with a PR. There is no dancing around that fact and doesn't affect the company negatively. So it seems like the only other outcome is likely a DMC recommendation of early halt for efficacy.
Now, FDA guidelines suggest that the company engage in a dialogue with the FDA with regards to such a recommendation from a DMC before deciding to halt the trial. Obviously, the data cannot be unblinded. Is it possible for the FDA to talk directly with the DMC and the statistician (with no intermediation by NWBO staff) to get a better handle on the data before they can give some guidance to NWBO about whether or not they encourage an early/rolling filing ? It seems like NWBO has already submitted trial information such as enrollment numbers, etc. and this was probably done about 6 weeks ago (a week after the last PR). But I'm pretty sure the FDA will need more than that to provide guidance on how to move forward, which was the reason for my earlier question about direct contact with DMC and the statistician.
Secondly, is it possible that the FDA could accept an early filing with the caveat that the remaining 48 or so participants will need to be enrolled (concurrently with the rolling filing) before the FDA issues a decision? Is this what the discussion with the FDA would entail? Is this what the company is waiting for, before we hear from them?
Finally, the reason for the screening halt is still a big mystery to me. If it is, as we assumed, for cost reasons, then an interim halt is still very much in play. Because if the halt was the company's discretion, then any indication from the FDA that the trial will need to fully enroll would have made them lift the screening halt by now. I just can't imagine why any regulator would halt screening but allow treatment to continue.
Many thanks for your help.
90 minutes and still nothing from him :)
I believe that has been posted before. The links etc. You have to keep up man!
Nuttiest post I have read to date.
What exactly did you "prove" in your point? Do you have evidence? Do you have a PR?
Hints of negativity you say ? You would love to be proven wrong you say?
Can I say that I would love to be proven wrong too? Sigh... NWBO cannot discuss a blinded trial until the FDA says so. How many times do you have to be told that?
You are a wall, and I would be crazy to talk to a wall and try to convince it that the ground that it stands on is weak and will tip over in about 4-6 weeks.
How about that? I know you won't like that because it's just mumbo-jumbo. But that's exactly what you're giving me.
You and Austin make such a lovely tag-team. Are you holding hands now ?
Lord only know how you can ignore "clues" in official statements that can subject the sponsors to legal liability and instead choose to believe in your imaginations. Good luck to you too sir !
Looks like you were not copied on the memo. Let me help you out. Go read their PR, the 8K and Les's email over the last couple of months. Your clues are there. I'm not as patient as Flipper and Senti, so you'll have to dig it up yourself.
What did you expect when the whole damn market is down? Do you believe in the fundamentals of this company or not? If you are expecting to see a straight line up, then I suggest you see a psychologist. We've had enough of another a bi-polar guy named Pyrr. You cheer-lead with "go NWBO" when the stock is up and start whining like a baby when the stock is down. Absolutely no value added. They say that if you don't have the stomach for volatility, then stay out of bio-techs. At least say something of value that we can appreciate. Blind cheerleading and desperation every other day is a big nuisance. If I have to tell you all of this, then it's a hopeless case.
Is that why you run scared when the share price drops or someone posts a contrary view that you can't quite comprehend?
That guy is a bi-polar nut who feeds off others' DD and starts crying whenever the price goes down. Why he is invested in a bio-tech stock is beyond me.
Well said Flipper, I wish you could hear me clapping :)
From 10-K as of Dec 31, 2014, financial statement footnotes, section on "Revenue Recognition"
Once again a mouthful of nothing.
TZOR, I needed that laugh :) But I have a nagging suspicion that we will see that day soon. But sorry, I have no data to support my suspicion :)
At the risk of repeating myself, NWBO showed its data. The data is there and Linda's money is on the line. You can read whatever you want into the data, and say it could be this, or it could be that. But unless you guys show me real data that contradicts what Linda presented, it's just conjecture and wishful thinking to support your arguments. You expect me to sell because of your imagination?
I will admit that you are one of the more intelligent contrary-view posters. Which is why it puzzles me why you would short this particular stock? It's a very risky short. If you really are short, I urge you to close out and look elsewhere for opportunities. But if you are a salaried employee, well, then I guess you need to do your job. But be warned that your employers could easily turn and go long and your services may no longer be needed.
If you gave me credible reasons for selling, I surely would. I'm not in this to lose money. But none of your arguments have any credibility. Mostly conjecture. Give me something I can work with.
Simple.
Market cap: 600M
Share price: $7.68
600M/7.68 = 78M
And may I ask you how you get 200M ?
The float is held by you and me and like-minded investors. As long as we hold tight, we may not need Turtle. Sorry Turtle :)
More importantly, when there is a secondary, we need to root for a private placement with a "patient" investor rather than a public offering. This will make it a lot more difficult to get out of a short position when good news comes.
The float is getting really tight. Total shares outstanding is 78M. Linda and Cognate together own 47%. Woodford Funds have 27%. Other institutions and mutual funds own approx 9%. That's a total 83% or 65M shares. Estimated float = 13M. I think the short interest is about 11M.
I'm not one who obsesses over short interest. But this appears to be extraordinarily tight.
Some people are hi-fiving themselves like the game is over, but the referee hasn't blown his whistle. Let's tally up the score when the game is over, okay boys ?
The AA scenario is still alive. It's still too early to have finalized FDA discussions. Don't delude yourself.
It appears that these types of advertising violations happen routinely. IN June 2015 alone, there were 4 such violations, and all seem to have gotten nothing more than a mild scolding.
https://www.gov.uk/government/publications/advertising-investigations-june-2015
If you noticed the last sentence in your original link, it states "Advice on our interpretation of the law was provided to Northwest Biotherapeutics". Doesn't talk about any follow up action.
It's very very unlikely that the screening halt is related to this.
That's correct. It makes sense that we have not seen a 13g for the Patient Capital Trust Fund yet because they must have breached the 5% reporting threshold recently and will be reportable as of 9/30/15. The Equity Income Fund has a size of $10.2 billion. The NWBO position in that fund as of 6/30/15 (using today's share price) is about 1%. It's not a top-10 holding, so it's difficult to determine the current position. If NWBO's position in the Patient Capital Trust is 4%, then it makes sense that he would/may increase the position in Equity Income too. However, the float is beginning to get really tight. My guess is he takes a direct placement from Linda in the coming weeks.
If I was so convinced that there was a negative safety or efficacy issue, why would I want to keep harping about it? The way I would benefit from my convictions is to let the stock rise as much as possible and then short it. So, yes indeed, it's strange that someone with such convictions should be relentlessly spouting negative views, unless.... (speculating here) I'm a salaried employee and it's my job to do it.
Here is some up-to-date substantiation:
Patient Capital Trust holdings as of 9/9/2015:
http://markets.ft.com/research/Markets/Tearsheets/Holdings-and-sectors-weighting?s=WPCT:LSE
It shows approx 6.7 million shares (4.0% times GBP 849 million).
Total in both funds = 21 million shares.
TC_trader, you are correct. The 13G very specifically states that filing is for the Woodford Equity Income Fund. Woodford Investment Management is the name of the company. There are 2 funds managed by the company: Equity Income Fund and Patient Capital Trust.
Equity Income Fund has 14,280,360 shares as referenced in the 13G filing. Now, Patient Capital Trust also owns NWBO shares (4.5% of the total fund size of GBP 829 million, or roughly equivalent to $56 million or roughly 7 million shares; see the link to their website).
So, if anything, I'm estimating the 2 funds together own roughly 21 million shares.
Question is, why don't we see a 13G for the Patient Capital Trust. Perhaps is coming any day now.
https://woodfordfunds.com/our-funds/wpct/trust-facts/
Yes, but what this tells me is that they are actively collaborating with a leader in the science, Linda Liau, on a potential combo trial. That's the main takeaway.
Yes, credit to RK.
I was intrigued and found this. Not sure if this has been posted before. NWBO, RevImmune and Linda Liau all mentioned as inventors in the patent application.
Have they found a partner in RevImmune for the combo ?
http://www.freshpatents.com/-dt20150723ptan20150202291.php
Last year I sat next to a young lady on an international flight who worked for a large European pharma who did audits of patient records of those who were enrolled in their clinical trials. She was an employee of the pharma. I asked if she could actually see details of patients in blinded trials. She smiled and said yes (because she sensed that I was a bit surprised). Anyway, now it confirms what Senti said. Take it for what its worth.
No one is talking about fast track my friend. There is a preponderance of signals that point to a possible halt for efficacy. Sure, it's not a certainty. There are many precedents for a halt and rapid approval. Now, I know you are going to come back with something inane. But I'm more interested in the views of others on this board.
Flipper, you had estimated that NWBo will submit its regulatory filing on September 4. The conference is on Sept 16. Wouldn't the FDA take some time to review the filing? What are the chances that LP will not provide us with an update on Sept 16 ?
On another question, given that the P3 is blinded, could the DMC provide any efficacy data directly to the FDA for review in conjunction with NW's filing in order to provide guidance regarding an AA ?
Thanks !