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I’m going to offer my unsolicited opinions on this week’s news...
The company is preparing for commercialization. The data we have all seen (including them) supports approval of this vaccine with one to four regulatory agencies. They’re anticipating this. They’ve now hired a CFO. They’re lining up manufacturing. They’re preparing to move forward with commercialization. Remember the “work in parallel” guidance? This fits the bill.
Datalock will probably come in the next few weeks. Topline will probably be announced in the first quarter. Full data by ASCO. I expect approval by the fall.
This is a 400 million + dollar trial and, despite the delays unblinding due to survivorship, I think ultimately it will be successful. The company thinks so too and is making plans in parallel for success.
Cheers to a prosperous 2020. I’m sorry for the long suffering investors who’ve had to wait this long for success. I hope everyone can add more shares in this, the season of tax selling and see great value correction when data and approval are announced!
Photonic5
Ex...you’re just wrong here. Hahn is a scientist and wants to be agile with trial design and endpoint analysis. When it is apparent that a trial is saving many people’s lives, he wants the agency to show agility to get the product that is saving lives to patients.
With positive topline and approval, this will make up for 10 years of lagging in 2.
A bonus occurs if he updates us on total number of patients alive at datalock and it’s more than 75.
I imagine that they’ll announce datalock today and provide a timeline on when to expect topline results.
I stand corrected. She would lose 6.5 million plus all the outstanding warrants and options that she has pending.
I’m still sure the salary here pales in comparison to the monetary and other personal considerations that a successful trial and commercialization would bring.
If shareholders do lose everything, as roughly 20% owner of the company (assuming a market cap of $132 million), Linda Powers would lose about $26 million with NWBO bankruptcy.
Is that making millions?
I guess that I should clarify that I nothing I’ve been told is information that would qualify as material disclosure. It’s really no different than Linda Liau saying “stay tuned”.
As an investor, it’s my personal discretion as to whether I “stay tuned” or not.
I have been told by the company that the company believes it has communicated clearly what stage of the trial we are in. I’ve also been told that as future progress endpoints are met, those would be communicated with investors, including the final datalock and a topline data report.
So wouldn’t regulators want to take their time in evaluating claims about their survival tail?
In the end, constructing, getting agreement on, and applying the SAP shouldn’t be this complicated. How to adjucate the trial PFS endpoint for psuedoprogression is, in my opinion, the biggest issue. I can’t imagine how difficult it might be to get four regulators to agree on a method for that when no standard for psuedoprogression detection exists.
In the end, mOS is the gold standard for evaluating efficacy for GBM. But failing primary endpoint (due to pseudoprogression) and a one month gain in mOS wouldn’t accurately reflect the meaningfulness of this trial. Evaluating a meaningful increase in three, four, and five year survival is where DCVAX should shine. But first, regulators have to agree to that.
Which regulators? The ones in Europe, US, Canada, or the UK?
Building consensus with a personalized immunotherapy that causes responses that appear to progression initially seems to be a ginormous task. I wonder if anybody is going to give a small biotech the benefit of the doubt with lots of big players influencing decisions.
That’s what we’re waiting to see.
$22 would be quite the correction, but, if efficacy is proven, the platform is definitely worth that much. What works in GBM could work on a wide array of cancers.
Time will provide clarity. I’m just impatient.
I think Dave is careful to express his personal opinions separate from information that would require official disclosure from the company. I’m sure there are things that he would love to share with shareholders that he can’t due to endpoints that aren’t completed. In my communication with him, he has shared that they won’t detail progress, but will share pertinent information as endpoints are reached. We, including him, are all anxious to get to topline on the L trial. I reviewed Ikeesq’s annual meeting notes again this morning and the review reiterated to me how complex this work is to get done with cooperation from all experts and regulators in four countries. The company never said...hey, this will be easy and quick. While I lament the time that finalizing the trial has taken (mostly for patients), I don’t feel duped by the company. They said with certainty that the effort would take time and be complex, as many experts and regulators are involved.
Maybe. I’m not going anywhere until after topline. I’m not afraid at these prices. You can believe that.
Source? Or...this is your opinion.
I totally agree. There needs to be some more transparency into the timeline of the trial analysis. Technically, they’ve been waiting over a year just to compile and analyze the data. That seems absurd.
My biggest issue at this point is the delay that the SAPs have contributed to the trial. This SAP process has now been dragging on for over a year. Why couldn’t this work have been going on in parallel to looking at blinded data in 2018?? If the company drafts the SAP and gets regulatory approval of the document in 2018 then, once the database is ready, they could have applied it and shaved 6 months off this process. Under those circumstances, they probably would have had topline data for us at ASCO.
Very disappointing that they dragged the data out, using SAP and regulatory excuses. On the other hand, our trial will have more information about long term survival than ever in GBM.
We’re all beyond ready for news...
It also doesn’t appear that they are anywhere as close to regulatory approval as $NWBO with their late phase 3 trial.
I’m frustrated with the lack of progress towards data in our trial. There is further progress to be made with other cancers using this platform. I spent last night getting one of my final visits with my aunt, who has advanced metastatic triple negative breast cancer. It was caught at stage 0 back in 2008 and she had surgery, chemo, and radiation back then. Eleven years later, it will kill her. I think it would be worth it to add DCVAX for patients like her when they’re stage 0 to find out if we can get a long survival tail, but it would probably take a 20 year trial. I hope someday the economics of drug development supports this work. This is where there is progress to be made in cancer treatment.
Our society throw plenty of money at this disease. It’s frustrating that one of our most promising technologies can’t be explored further due to poor market capitalization of the company that owns it.
Let’s get this trial unblinded and the results analyzed.
One of the attractive components of NWBO is how tightly held it is by retailers and management. That will add a premium to the correction with topline and approval.
What’s interesting about this article is that they stated later, in 2017, that they were still waiting for OS events to accrue. In effect, the need for dilution is the prolonged survival in the trial population. Hindsight is 20/20. Linda most certainly should have diluted more diligently at $1 levels than at .20 levels. But, either way, an effective trial followed by approval will give us a product worthy of generating revenue. Probably significantly more than the $1 billion per year stated in the article.
I’m not sure that SNO was their target venue. They’ve telegraphed that, until the final unblinded data is ready and analysis is blessed by regulators, they aren’t going to say a word.
And they’re really good at keeping secrets. This clearly isn’t a big operation with lots of whisperers.
My hope is that it’s a total surprise to the market. Something along the lines of BPTH last March.
I have a sense that something big and positive is coming near term. The excitement in management, patient advocates, and researchers is palpable.
I’m hoping for a healthy dose of Christmas cheer for GBM patients.
If they reveal that there are still 50 or more patients alive in this trial 4 years after the final patient was treated, there would most likely be a reaction in the share price tomorrow.
I get every indication that they are keeping the strong hands close and and letting the weak ones flounder.
If that’s the case, I’m expecting a PR tomorrow morning prior to market open. Much like last year when Dr. Liau presented at SNO.
Why would the title of the PowerPoint be Updated? Was that a rehash of last year’s “updated” or new “updated”?
Please share your January assessment of jet costs vs renting with other very naked longs on this board. Your post made my day.
I agree with this. I think we’ll get some kind of update of progress at SNO.
What is the correlation between today’s share price and unanalyzed data from their blinded P3 trial?
You expected the company to be sitting on a multi-billion dollar market cap prior to unblinding the results of their critical P3 trial? Based on what? Interim results and faith alone?
If the trial results are as good as we expect, the correction will be epic. We’re almost to the top of the climb. The ride up could be a lot of fun.
What don’t you know about the process from here? Get the SAP completed with regulatory buy in, the unblind the trial, and then publish results. It’s fairly simple, yet so many on this board are trying to generate this conspiracy theory that the company is lying or hiding critical information regarding the trial to generate salaries for themselves.
The only conspiracy theory I see is that those generating these narratives are trying to scare investors into selling before results. They’re probably being paid by parties looking to scoop up cheap shares or force the company into bankruptcy prior to successful trial results can be published and approval becomes imminent.
He shared the exact same wisdom with me and he’s right. We (including NWBO) all want this done as quickly as possible, but when working with regulatory agencies, the timeline is out of their hands.
I agree. Shorts are probably gone here. I was talking about if there is an AMRN buyout.
Short interest could pick up if we get back up over a dollar.
The shorts in AMRN got roasted last September. Next roasting will come at buyout.
I agree. NWBO could have submitted the “completed draft” to regulators months ago. I imagine they’re long into the process of getting “buy in”.
What is frustrating is why this work couldn’t have been done in concurrence with moving forward in 2017/2018. Why wait until they’re fully ready to unblind to draft the SAP? The SAP work seemingly could have been done in 2018 and applied to data last November. What are they learning now that has delayed this SAP draft process? Whatever it is, it brought Dr. Duffy on board.
I expect our next announcement will be data lock and unblinding. The beauty of that process is that it eliminates subjectivity. Once the SAP is drafted and agreed upon, the final process is completely objective. Final process is apply the SAP to the unblinded data and get the trial results. Topline will come first, but there will be a ton of data to be analyzed and published in this trial, including patient subgroup performance. I expect we’ll learn quite a bit about DC vaccines.
It’s a VERY exciting time. We’re really close to the end.
Psuedoprogression may confound PFS. But OS will not be influenced by pseudoprogression and should show a huge improvement based on interim data.
How would anyone know if this trial is blinded?
Keep in mind, we know in some patients that the vaccine has demonstrated a measurable immune response. Dr. Liau has stayed as much.