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Well, that would certainly be the best reason/result from a patient and shareholder standpoint. If that is the case though, why did it take so long? Even if the answer is that patients were still living, then efficacy could have stopped the trial long ago.
Sojo, I do not consider $1.44 to be a spike! I meant back up over $2+
I don't think Sawston news will do that. I hope the peer-reviewers are from a Journal, but we just don't know. We also do not know when they started the process. A lot of unknowns.
I am convinced the next news we will get will be about Sawston. Doubt it will be a game-changer with PPS. If we are lucky, LP will also insert new cryptic language about the "process." Hopeful I am wrong on topline and Journal in early 2022.
We don't even know what the actual, official trial end date is. I have asked. I thought it had to be August 2020 PR at the latest. Certainly has to be before October 5th Data Lock PR? That ambiguity and use of covid delays likely takes any firm reporting date requirement off the table.
Yes, this process would suggest the article has been accepted and currently in peer-review. OR, it means NWBO's scientific advisory board and in-house experts are still reviewing prior to Journal submission. Therein lies my frustration. Which "step" in the process are we in? They could tell us.
She is doing the same as Duffy, CFO, etc....brought in, told one thing and then nothing happens. Then they leave or get reassigned.
FeMike's conversation with DI tells me two things. One, sounds like peer-review is ongoing. I can't imagine an expert in GBM not expediting review and comment if data is as good as I hope. They will want to get this news out so patients can benefit. Obviously, can't be expedient at the expense of critical review and to diffuse naysayers. Two, 2021 may be out of the question for release of Topline data and Journal. Who knows though as we do not know when they got the data to experts for review.
Did Anyone catch NWBO lunch talk today at the ABTA conference? Or did they not show, again.
I will be looking for something PR'd by the company in the next week or so. If not, I believe JDheart is correct and we will see a bear raid again, to new lows. With no news I will likely be trading the stock for the first time in 7 years.
Blinded interim survival data showed the median OS for the intent-to-treat (ITT) population was 23.1 months from surgery. This was an improvement from the median OS for the standard of care. Interestingly, patients with MGMT methylation had a median OS of 34.7 months from surgery with a 3-year survival of 46.4%. Furthermore, there was a population of extended survivors (n = 100) with a median OS of 40.5 months, which will be further analyzed. However, the study did not provide the IDH status of these patients. The adverse events with DCVax®-L were comparable to standard therapy alone. Final results from further analyses and follow-up have not yet been published.
IDH mutation status and data was one of the major delays in getting to data lock.
Reiteration of the exact same language "refer back to the October 5th PR" of the same process is not an update. They could easily tell us what boxes have been checked or what is left in the process, all while not showing their hand or giving specific dates.
Wouldn't everyone think that they HAVE to say something by October 5th? Can you truly believe, symbolic or not, passing 1 year without a true update would be possible?
Yes, she was. She was on the agenda. There is nothing on this year's agenda for NWBO, LP, LL, MB, etc.
Duh. My point was that I asked for updates on these items to all shareholders. There are many things they could be saying to keep the morale and interest in the stock up while they get to topline. They continue to hide behind what LP considers to be "material" for release. When a CEO is looking through Attorney glasses, nothing short of SEC-mandated disclosures will be offered. That's been my issue all along.
Me Three, as you all know! I have stopped getting replies to inquiries from the company. Since they can't (won') talk about the trial, I have asked other questions so as to make educated decisions around my holdings.
Things like:
We are likely low on funds, what's the plan?
$11 million loan, payable starting November.
Warrant conversion suspension and extensions
Official trial end date
1yr from data lock soon
Can you even do significant financing right now?
All would be important to know since we have no idea on where we are in this "process"
Someone is clearly dumping shares. Could be conversion and sale. Could be a frustrated long. Could be a financing dump we haven't heard of yet. Maybe LP converted the $11 million loan to shares and they are selling. Who knows. We never know with this company. What is known is that there isn't enough visibility and awareness of this company to get enough buyers to balance the selling. OTC, no institutional buying, etc.
Agree that something has to give. We have the 1yr data lock anniversary in less than a month. We have the $11 million loan repayment starting in seven weeks. MHRA production certification/approval next week or thereabouts.
I'd love to believe that but you used "sane" and "imminent" in the same sentence while discussing NWBO. LOL.
I don't disagree with where we are. I disagree with how we got here, that's all. As far as "Linda’s strategy for extracting the existing potential and intrinsic value of this platform before any unwanted early sale of large chunks of the company"....I would say having potentially more outstanding shares than authorized would disagree with that statement.
There seem to be a lot of posters on this board who are very confident in their posts, when in fact, it is pure speculation. They may feel their deductive skills are better than others, that's fine. But the truth is, we don't know. No One knows except LP.
So, in the spirit of those who know it all, I am 100% confident that a more transparent process with real updates along the way would have been better for the company and shareholders.
Again, agree to disagree. My general disagreement with the strategy from management is just as valid as your "specific" speculation. That is so since we have no idea. Like all this talk on ihub about Duffy this weekend? Really? He could have come and gone because he didn't like the way LP was running the company. He could have left because he didn't see the science going anywhere. I don't believe that is the case but it is just as possible as him being some sort of due diligence spy.
Every public company is looking for new investors and to keep the investing industry aware of the potential of what they are building, selling, servicing, disrupting, etc. DI was hired to get more investors, that's his job. We have been quiet in the investment world for years, except for the negative press of the Woodford debacle. With better stewardship we would never have been delisted, IMO. If you consider the vague "process" that was described a year ago as "updates," we certainly disagree.
I'd rather not be speaking this way. Many people here will wait forever with no accountability, IMO. Yes, over one year ago topline was two weeks away. Then they go dark for a year with no updates whatsoever except "refer to the vague October 5th PR."
It would certainly be more exciting if they would be invited to an investor conference, like ImmuneBio, rather than pay to be a sponsor at an event where they get to say nothing.
So, looks like we have an expensive sponsorship for the conference next weekend and no presentations. What’s so exciting, what am I missing?
LOL. Every day is "possible," just not likely, unfortunately.
Yes, but kind of irrelevant if you don't have any money to fight potential violations. Patent violation fights are a very expensive proposition.
Even if they get manufacturing cert for Sawston, capacity doesn't equate to revenues unless someone pays. And, in this case it's out of pocket. Tough Ticket. And, those investigating compassionate care for a GBM will also look for topline release, if they have time. Even if they got to full capacity with patients able to pay, $120 million per year annual revenue and maybe $50 million profit is $.05/share. So, we would essentially be properly valued at these levels as a "growth" company. Topline is still all that matters.
I think there will be a problem with financing. Good Sawston News does nothing to help that IMO. We don't have a product to make! We are not going to get favorable terms for a compassionate care "product." The excitement about Sawston was predicated on near-term positive topline data to go with production capability. Without topline, spending money at Sawston looks like the cart before the horse or potentially NWBO having a secondary business option if data is not good enough.
We are a month away from one year past data lock
We are two months from large loan repayment obligation beginning
We have no idea where in the process we are.
NWBO needs money, what will they do?
Can they do anything significant prior to releasing topline?
No details, but that's how I am reading it.
I do not expect a single reply to my question. I am hoping many frustrated shareholders are asking for a legitimate update on the process. This year-long quiet period is ridiculous, IMO. They could tell us which boxes have been checked without giving away an exact date (which they stopped doing after last years rolling-topline release date debacle).
Has anyone even tried to reach out to the company to push for an update? We are less than 5 weeks from hearing nothing about results for an entire year!
I honestly don't think it means anything. Duffy is a journeyman middle manager, IMO. I don't believe there are any buyout or partnership talks going on and won't be until NWBO releases data ad Journal. We have been the sheep crying wolf about new trials for a decade, who would want to go down that road when you have no money to do them or you keep saying you will start them and don't. We are waiting for the binary event, period. Then we will see what happens.
Did the other minions sell?
There MUST be regulatory filing dates and deadlines. Whether they follow them or how strict the enforcement is, who knows.
The ARE financial issues moving into the Fall. Short on money, not short on expenses. They clearly feel they can do some interim loans, etc, as we saw in last 10Q, to try to get by. I believe any large financing or share sales at this point would be difficult in "quiet period"
The fact is, we are almost a year from data lock. ZERO info on trial or timeline. Can't change LP's mind at this point, and I get that they want topline and peer-reviewed article in lock step. You can still give shareholders an update without showing your hand. If Covid is truly the reason for delays, an this trial is the only thing nwbo has to potentially keep it afloat, I believe it is a material event and should be disclosed.
I don’t see how nwbo can get to October 5th without topline. There has to be an official end to the trial. It had to be prior to data lock. My fear is that we will get a PR citing COVID delays and an indefinite extension.
I believe your estimate of 5-10B prior to FDA approval is realistic with multiple endpoint success. I personally don't believe we will get to FDA approval as NWBO, it will be bought.
It's been a relatively low-volume walk down so far, points back up to me into the close.
All depends on today's close, IMO. That would be an ugly candlestick if we end near lows of the day. If we gat at least half way back up, it would be viewed as a test of DMA's and make a run again tomorrow. If we close near lows of day, I believe we go down again tomorrow.