theorysuit
9分前
You quoted Les as saying, "the other places that gave us permission to do the trial, that was four different countries". And of course, those 4 include the US where we actually started the trial, designing it by FDA standards and where we ran some 86 trial sites, so we obviously will apply here, but only after the Flaskworks Eden system is up and running.
Can you quote where NWBO said they would submit to the US FDA and that they would do so after EDEN? You can't quote it because they NEVER mentioned the US FDA. And why is that? The FDA meets with companies after phases in trials to discuss next steps. Can you say New Trial Design Needed? You talk about BS, you speak it.
Q1 going to end and you lemmings are going to blame the MHRA and float out Q2 2025. I already know it. This is going to get rejected no doubt in the UK. There is no narrative change. That only happens on the pump side. The experts of blame and changing narratives for this POS garbage company on the OTC. FAFO.
beartrap12
11分前
Froggmister, FUDsters complaining that NWBO will never submit an application to another country is the latest, newest, brightest negativity item they are all throwing out there for newbies to hear. What I hear in that comment is that they've let go of the notion that the UK will not approve DCVax. Of course they will apply to the countries that supported the trial and of course they've talked about it already! Besides Les, here's Linda Powers at the ASM:
Of course, we are anxious to submit applications for approval in other countries. We are very happy to be going through our first process in the UK because they have the fastest process of any that we know of, and it’s been really great, but of course, we want to start getting applications put together… and that’ll be another thing we’ll be working on during this period… and getting those prepared and submitted. We have a partial head start on them because one big component of the application anywhere is the “clinical study report”, which is a ginormous document that has the 20 years of efficacy and safety data from every program that’s ever been done in DCVax, even programs other than brain cancer. So we have a partial head start, but applications in other countries will be important. ??
You quoted Les as saying, "the other places that gave us permission to do the trial, that was four different countries". And of course, those 4 include the US where we actually started the trial, designing it by FDA standards and where we ran some 86 trial sites, so we obviously will apply here, but only after the Flaskworks Eden system is up and running. As Skitahoe notes, management expected to start under the artisan method and that method will not be able to handle all the needy patients in the US.
I would lilke to think that EDEN is close to being operational, but we'll see. IMO, news in NWBO's favor is about to explode!
skitahoe
9時間前
I know some people don't agree, but I don't believe the current manual production facility approve for use in the UK has sufficient capacity for the UK along, if that's true, until they have more capacity filing with other regulators isn't possible. The EDEN is the key unless someone's building lots of tiny cleanrooms somewhere. I don't believe that tiny cleanrooms are being built by anyone, I believe the company, and any contract manufacturers, are waiting for the EDEN.
I believe the company is working on what's needed to file with each of the regulators, but nothing can be done until a commercial production facility can be inspected as part of the process in considering approval. No approval can be granted if no production facility exists.
Gary
froggmister
9時間前
I also do not recall that NWBO mentioned its intention to submit applications to
the EU. If that fact can be taken as evidence, we should also assume that any
potential treatments developed from the combo trials at UCLA, Roswell
Park, the DCVax-D trials and any future partnership trials, will be limited to
the UK market. What a waste that would be.
Les Goldman on Aug, 2023 Big Biz Show:
The first one will be to the MHRA in the UK which is allowing us to do this specials program even before we file, but we're we're getting much closer to being finished up with 1.7 million pages long it's got 27 modules uh it's being double checked now to make sure that it’s completely consistent. So we'll be applying there, and we'll be applying then to the other places that gave us permission to do the trial, that was four different countries including the UK, including Canada, and including Germany and we'll be filing in order in each of those places for a commercial approval and then we will go into operation on a completely commercial basis.
meirluc
10時間前
"There is a very real chance NWBO never submits a BLA for DCVax-L.
They have never, not once, said anything about plans to submit to the FDA."
I also do not recall that NWBO mentioned its intention to submit applications to
the EU. If that fact can be taken as evidence, we should also assume that any
potential treatments developed from the combo trials at UCLA, Roswell
Park, the DCVax-D trials and any future partnership trials, will be limited to
the UK market. What a waste that would be.
I don't believe that to be very realistic and instead believe that NWBO will tell
us something about the goals of future combo trials (e.g. tumor shrinkage)
but not about the identity of intended partnerships or intended targets for their next
application for approval. The only exception to that was that they did not hide their
intent to submit their first application for approval to the MHRA.
skitahoe
10時間前
Barnstormer, from my involvement with other biotechnology companies I don't believe that NWBO is that different from the others. Some were not as silent, but when they tried to guess what the regulators would do, all to often they were wrong.
NWBO certainly is pretty quiet, but that's better than being wrong. I suspect that they expected action from the UK by now, but they can't force it to happen. In nearly every case they are at the mercy of others. I think that we're getting close and by next week most key people will be back from holiday vacations, hopefully things will start to happen.
Gary
Lykiri
12時間前
Approved 10 months from the first CHM meeting!
The approval is based on findings from the phase 2 DeLLphi-301 study (NCT05060016).
DeLLphi-301 [NCT05060016], an open-label, multicenter, multi-cohort study, did not include a comparative placebo arm.
This product (Tarlatamab) was submitted and approved via a national procedure as part of Project ORBIS.
On May 16, 2024, the Food and Drug Administration granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc.) for extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy
dedugan
13時間前
I would like everything you said to be true.
But you said "We have had a number of sources close to Moez Kassam write to inform us that Moez/Anson have recently received a sealed indictment.
According to these sources they have been found guilty."
An indictment is not a guilty verdict. Indictments come from grand juries, while guilty verdicts come from regular, or petit, juries.
The problem is that you have conflated the two, and therefore everything you said thereafter has to be treated with a with a thousand grains of salt.
If your sources conflated the two, they cannot be trusted as reliable, and that makes your whole post nothing more than the drivel that comes from fuds.
Do better.
barnstormer
13時間前
Gary, I have to admire your ongoing positive attitude and outlook over these years, especially in view of some significant health issues you've had to deal with. I'm almost your age and have remained pretty healthy for the most part but having accumulated shares in the company over the past 14 years I find myself getting more frustrated with the lack of information it provides. Maybe it's I've become increasing aware over the years that all of us (and that includes companies) are finite and should be judged on how effectively we used the time allotted to us, resulting in an increased lack of patience on my part.
The delay in the MHRA decision is frustrating, but I came to the conclusion months ago that the 2024 goal was just a goal, nothing more, and that the agency had failed to make any significant progress in cutting through large 2023 backlog, much less the subsequent 2024 one. That was substantiated by the recent December report confirming that, including staffing and funding problems. Well, we are dealing with a government agency, so expecting efficiency is unlikely.
The continued lack of any information on any EDEN progress is more a of a current concern to me. The company has had the technology for over 5 years and hasn't mentioned it for nearly a year. Progress on clean room aside, there hasn't been a mention of any progress on a working production unit for nearly a year, and that was only on the design. Checking my notes I believe they were considering had two possible approaches at that time, but be it one or two, why can't the company provide some information. Not looking for any secrets, just an update on progress. Even if the news isn't great, it shouldn't have a huge impact on the share price, which in mainly tied to the MLHRA decision.
richdag
13時間前
Legal short sellers were covering the day after NWBO's financing announcement on the 26th as evidenced in my account records for Fri the 27th. As of the close on the 26th, I had 500,500 shares loaned out under Fidelity's Fully Paid Lending Program. Then sometime during the first couple of hours last Friday a total of 487,097 shares were returned to my account in separate lots as follows: 289,500 shares + 10,500 shares to one account; 27,374 shares + 9,223 shares to a second account; and 150,500 shares to a third account.
What this signals to me is that these LEGAL short sellers have gotten the message from the new NWBO financing, and have correctly concluded that the upside risk now exceeds any further downside potential.
The 487,097 shares formerly loaned and now returned to me accounted for a little over 10% of Friday's 4.6M volume. For those not familiar with lending shares to shorts, the owner of the shares gives up NO rights what-so-ever, can revoke the loan on a moment's notice, can sell his loaned shares at any time, and can exert negative pressure on the short seller if he wishes. On top of that the lender (shareholder like myself) collects a handsome interest rate, credited daily to his account.
eagle8
14時間前
kristen shaughnessy
@kshaughnessy2
"...From what we are hearing, the Feds want Moez and his senior team in handcuffs.."
Illegal Naked Short Sellers Are Turning On Each Other
"We have had a number of sources close to Moez Kassam write to inform us that Moez/Anson have recently received a sealed indictment.
According to these sources they have been found guilty; however, as cooperating witnesses, that information is being kept from the public for now whilst they are used to assist with the ongoing investigation.
This only buys them time.
Despite this, they continue their illicit shorting schemes...
It is rumored that Anson Funds offered the Feds over $50 million to reduce charges, but their offer was rejected.
From what we are hearing, the Feds want Moez and his senior team in handcuffs.
So who is Moez rolling on to secure himself a better deal?
Well, Andrew Left, of course, along with Adam Spears, Matthew MacIsaac (MMCap), Dan Davio (Canaccord), Mark Bistricer, Michael & Aaron Serruya (we have heard they should be very worried), Graham Saunders, Nate Anderson, CIBC, TD, and many others.
All concerned should be, and likely are, increasingly nervous with the knowledge that Moez will do or say anything to save himself.
Dan Davio, Canaccord CEO, is not sleeping well, for instance.
Davio and Canaccord have had a huge number of dealings with Anson Funds in the past.
Davio is at the top of the hit list, and if our sources are correct and Moez has received a sealed indictment, Davio will be one of the people he is helping to bring down.
Moez apparently has the goods on him, and is loyal to no one.
Davio knows this well.
Mark Bistricer appears to be having a nervous breakdown.
Reportedly, Marc has also been feeling the heat and has taken to making threatening calls at night under the influence of alcohol.
It only took a few years for him to go from the “smartest man in Canada’s markets” (in his mind) to one of the most scared.
This is a repeat offender and partner of Moez on multiple deals.
Marc knows Moez will roll on him in a heartbeat, and Moez knows where a lot of the bodies are buried
Everyone mentioned above should be aware that whatever Moez is saying to you is a lie.
He is poison.
He will pour honey into your ear and stab you in the back at the same time.
Most of you deserve the destruction he is bringing to you though...."
Courtesy -
@stockmannnbroo
theorysuit
16時間前
The meeting results were not made public and you're speculating on what they said.
So you're pulling stuff out of your ass. How do you expect them to apply to the FDA when their manufacturing is in the UK?
Then why are they forgoing the US for submission? You absolutely can apply to the FDA with non-US mfg...absolute BS and confirms you are first time bio investor. SMFH, you are the one making sht up.
Yes, you can apply for a US FDA Biologics License Application (BLA) with foreign manufacturing.
Requirements:
Foreign Establishment Registration: The foreign manufacturing site must be registered with the FDA.
Compliance with Good Manufacturing Practices (GMPs): The foreign site must comply with FDA regulations for GMPs, which are stringent quality standards.
FDA Inspections: The FDA may conduct inspections of the foreign manufacturing site to ensure compliance.
Data Submission: You'll need to provide comprehensive data demonstrating the safety and efficacy of the product manufactured at the foreign site.
A post-Phase 3 US FDA meeting typically occurs after the completion of pivotal Phase 3 clinical trials for a drug candidate.
Key Objectives:
Finalize Phase 3 Study Design and NDA Readiness: The primary focus is to ensure the final Phase 3 study design is robust and addresses any outstanding concerns raised by the FDA. This includes:
Confirming the primary and secondary endpoints: Ensuring they are appropriate, measurable, and clinically meaningful.
Reviewing the study population and enrollment criteria: Ensuring they are well-defined and appropriate for the target patient population.
Discussing the statistical analysis plan: Ensuring it is robust and appropriate for the study design.
Preparing for the New Drug Application (NDA) submission: Addressing any outstanding issues related to the NDA package, such as manufacturing, chemistry, manufacturing, and controls (CMC) data, and nonclinical data.
Gaining FDA Alignment: The meeting aims to ensure alignment between the sponsor's plans and the FDA's expectations, minimizing the risk of delays or rejections during the NDA review process.
Addressing Potential Concerns: The FDA may raise concerns or questions during the meeting. The sponsor can then address these concerns proactively and potentially modify their plans accordingly.
Outcome:
Clearer Path to NDA Submission: The meeting helps to clarify the regulatory pathway for NDA submission and increases the likelihood of a successful approval.
Reduced Risk of Delays: By addressing potential concerns upfront, the sponsor can minimize the risk of delays during the NDA review process.
Improved Communication: The meeting fosters open communication and collaboration between the sponsor and the FDA.
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