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I don't know how quickly a new Prime Minister takes over in the UK, but I doubt if it takes as long as here in the US, but we still might get approval before it happen.
How well insulated is the MHRA from political pressures in the UK. In particular will the landslide Labour victory in today's election make any difference, one way or another, in our MAA application?
It looks like the Phunware case is a couple or so months behind where we are in the Citadel case. Posner is now working on the amended complaint for Phunware. Then it will go back and forth on the motions for and against, and possible oral argument and then they will be waiting on the Judge in that case to rule - which is where we are now in the Citadel case - waiting on the judge to rule.
Thank you for that. I simply overlooked the icon at the end of the line which was right under my nose.
Does anyone know how to down load a copy of the audio file of the ASM to your computer for future reference. The audio plays well but will only be available until Sunday. I have tried to make a copy or down load the audio file but have not succeeded.
I would have started your list from Sept 1, 2020 to include the purchase of FlaskWorks - a major milestone.
BullS...
As far ad I am concerned there has been a lot of spilt ink on whether it is in 70 days or 70 or 60 or 150 days etc. and all the pointless details and arguments and trying to follow the bread crumbs on these details,
As a long I am confident that the result will be positive at the end of the process whenever it will be. I am happy to consider the whole MAA approval process as one black box whose internal details are not important to us(unless you are a trader) and think this entire discussion about the internal timing is a massive waste of time.
Many posters seem to assume they are one and the same thing - that may not be the case. I thought the point was pretty obvious!
His friend believes BP is behind the spoofing,
attilathehunt Maybe, just maybe the MHRA submittal bombed out and they are scrambling to right the ship thus the 150 day time line is no longer in play. Just guessing on my part.
☑️two phase 2 trials currently underway with the Roswell in-licensed technology that are fully funded by grants and being carried out by investigators
I think it is not at all clear whether the "inspections" and the RFI are synonymous or unrelated events. We know about the "inspections" for quite a while now but have still not received the RFI???
I have added one more question for the ASM which I sent to DI as below:
Hi,
I have one more question to add to the list I sent to you on June 25, for this ASM on June 29.
3) Have we received an RFI from the MHRA as of yet re the MAA application for DCVAX-L? If so, when did we receive it and will you need the full 60 days to respond?
Best regards,
............................
From: ................................
Sent: June 25, 2024 8:45 PM
To: 'Dave Innes'
Cc: ...............................................
Subject: Questions for the ASM Q&A on June 29, 2024
Hi,
1) This question concerns the plan that management has for the future development schedule of the EDEN system to shepherd it through the regulatory pathway to approval? In which and how many jurisdictions will this take place and when and where do you expect approvals for commercial use of EDEN.
2) Why have you delayed the submission for regulatory approval for DCVAX-L for so long after the submission to the UK for their MAA? Will these submissions to the FDA and EU for commercial approval require significant modification to the submission already made to the MHRA, and how much time might that take? Have you used the last 6 months to do this work? When do you now expect to make these submissions to the FDA and EU and by when do you expect these approvals?
Best regards
................................
Questions sent to DI for the ASM Q&A on June 29, 2024
Hi,
1) This question concerns the plan that management has for the future development schedule of the EDEN system to shepherd it through the regulatory pathway to approval? In which and how many jurisdictions will this take place and when and where do you expect approvals for commercial use of EDEN.
2) Why have you delayed the submission for regulatory approval for DCVAX-L for so long after the submission to the UK for their MAA? Will these submissions to the FDA and EU for commercial approval require significant modification to the submission already made to the MHRA, and how much time might that take? Have you used the last 6 months to do this work? When do you now expect to make these submissions to the FDA and EU and by when do you expect these approvals?
Best regards
....................
. If they get a deal with say a BP they could get a vg price. If not, and they would be pretty unlikely to have a deal with a major investment bank from the looks of it, then at best they get a deal with a hedge fund that may or may not be looking for quick in and quick out vs real investment. That means that they may or may not get really raked over the coals by somebody who knows they've got all the leverage.
In short the MAA could be followed by a very positive deal but that is far from guaranteed from where we sit. There may or may not be a devil in the details and whichever it is will mean a lot to the share price and strength of the same going forward. Going forward how fast or slow they can roll out in the UK to start lowering their cash burn will be huge if they are going it alone with funding from a hedge fund. If they get a deal with a BP, the largest concerns about the rollout going well are probably quite mitigated. If not then they need more money on a continuing basis and their ability to roll it out comes into question.
Coming from a long, I am surprised how close to a soft bash this sounds like.
I'm afraid it's become very clear that they are not likely to get instant stock market acceptance just from announcing an approval that they have not generally been given credit for being even possible. WTF do I know on whether or not that could change everything in one stroke.
Hi Jack, I live in Canada and looked into this a while back. I wanted to move a little of my shares into my TFSA. The bottom line as I discovered was that while it is traded on the Stuttgart exchange, it only does so on an over the counter basis and is not listed for regular trade on that exchange - so bottom line, I was not able to move my shares into my TFSA. We will have to wait until NWBO gets up listed, but then it will be much more valuable and we will only be able to move much fewer shares for whatever room we have available in our TFSA. But do your own DD.
That makes no sense. How can you (in DTCC world) loan out these share that you do not own (from DTCC world to retail level)? What does the lender of these shares provide to the borrower to show that he has proper shares to lend? Are the borrower and lender of these shares in cahoots?
I am not challenging LP's work on the Roswell deal. I am just trying to understand the detail of how we benefit from it.
It makes no sense. If all this naked shorting is only at the DTCC level, then how does this get felt in price change in the overall market - i.e. the market that retail take a part in? So somehow retail sees this share price coming down, but can not buy or sell in response to these virtual prices available only at the DTCC level?? Something like spoofing, where the price is posted for a brief period but retracted before anyone (at retail) can react to it? There has to be some real meaningful connection between what "happens" at the DTCC level and what happens in the retail market that you and I play in, for it to have any effect down here!
Yea, but that still does not explain what happens to all those billions of virtual votes in the mean time?
GeaorgeB, so what are we getting from Roswell - these vaccines are not theirs, so is it only IP that did not make the cut to get into clinical trials as of yet? This stuff may take many years to have any value and require mucho mulla to get there. Is there any immediate value to this deal or only padding the nest for the future?
AEK posted as below, is he not correct? Does Roswell not have any proprietary position in any of these vaccines? Are they only one of the trial sites - perhaps leading trial site - but with no proprietary position?
Currently, Roswell Park has two cancer vaccines available to patients through clinical trials. A vaccine called SurVaxM was developed by neurosurgeon Robert Fenstermaker, MD, and scientist Michael Ciesielski, PhD, to treat glioblastoma, ....
SurVaxM targets a protein called survivin found in glioblastoma cells and which helps keep the cancer cells alive. In phase 2 clinical trials, 63 patients with newly diagnosed glioblastoma received standard therapy plus SurVaxM. The study found the treatment was tolerated well and side effects were mild with low toxicity. Most promising — nearly all patients did not see their disease progress for six months and survival was extended for many. Some 51% of patients survived at least two years after diagnosis and 41% survived at least three years.
The study is now in phase 2B trials at 15 sites across the United States and China.
"Preliminary results suggest patients seem to be living longer with the novel treatment than with only standard glioblastoma treatment,” Dr. Puzanov says. "We have high hopes for advancement to an FDA-approved drug.”
Clinical trials of a cancer vaccine called CIMAvax also are underway at Roswell Park for patients with certain lung and head and neck cancers. The trials are evaluating whether giving CIMAvax, along with the immunotherapy drugs pembrolizumab and nivolumab, can improve outcomes for patients with non-small cell lung cancer or squamous head and neck cancer. CIMAvax targets a protein receptor called EGFR, which aids tumor growth and development.
Another vaccine in the pipeline at Roswell Park has shown promise in the laboratory. This dendritic-cell vaccine appears to improve the effectiveness of radiation therapy against some aggressive and treatment-resistant forms of breast cancer. ....
Senti, I never understood this. How does NWBO management determine which votes are legal and which are for fake shares bought from naked short sellers in any shareholder proxy vote?
I could imagine that if there are less votes cast than there are outstanding shares, then there is nothing pressing to say that any of these are illegitimate votes (even if some are not legitimate votes assuming NWBO can not differentiate between them). If however, there are more votes cast than there are legitimate outstanding shares, then we have a real problem that we can not escape. How does management resolve this issue at each call for a vote of shareholders?
This looks great. Good science in DCs that complements the science at NWBO.
Can someone please clarify, does the agreement with Roswell now mean that NWBO is in control of say SurVaxM and CIMAvax etc are now all part of the NWBO EXCLUSIVE arsenal of vaccines and whose development is already fully funded by grants, not needing a penny from NWBO?
thanks, not really particular, but I like the response.
I hope you are right, and hope to see evidence of this in the future.
Specifics please - no generalities!
DL's reply is all generalities without any specifics with details. Please highlight what part of DL's reply you are referring to in reply to my question.
Since LP saw fit to pay for the IP of Roswell Park I am sure there was something there that would be useful for NWBO and could be developed in the future once the DCVAX platform has been put on solid footing with approval in several jurisdictions.
What I would like to understand, is exactly what in particular are the points that Roswell's IP has, that NWBO wanted to develop further? NWBO already has a platform for all solid cancers. In what particulars does the new IP provide that helps with what NWBO already has, OR what new avenue does this IP open to NWBO that it does not have at the moment?
Here is one of them from Nov 2019:
“MimiVax is committed to disrupting cancer through the development of highly innovative immunotherapeutics aimed at increasing patient survival rates, so we are very excited to be working with Fosun Pharma to bring SurVaxM to China,” said Michael J. Ciesielski, Ph.D., MimiVax chief executive officer. “Fosun Pharma has both the expertise and access to reach this fast-growing market.”
MimiVax’s proprietary product portfolio is based on technology licensed from Roswell Park Comprehensive Cancer Center that targets survivin. The therapies are designed to stimulate immune responses to control tumor growth and recurrence. The company is now working to initiate a pivotal randomized study of the use of SurVaxM in treating patients with newly diagnosed glioblastoma in 2020 to be performed at cancer centers across the United States and in China.
OK, I thought along those lines as well, but then we need to know exactly which deals with Roswell are included in the "exclusive" package and which are not. Without the fine print of the deal we won't know these details
OK, if so, what did the other 90 get in their licensing deals?
OK, if so, what did the other 90 get in their licensing deals?
"The portfolio (that NWBO just) in-licensed from Roswell Park is complementary to, and builds upon, a portfolio which the Company (NWBO) exclusively licensed from another institution last year. Together, the two portfolios encompass more than 20 years of work by one of the foremost groups of dendritic cell experts, led by Dr. Kalinski."
and Melanoma.
Thanks for adding nothing!
From Beartrap's earlier post:
"Dr. Kalinski and colleagues have built a compelling case in support of their out-of-the-box approach to cancer immunotherapy," says Kunle Odunsi, MD, PhD, FRCOG, FACOG, Deputy Director and Executive Director of the Center for Immunotherapy at Roswell Park Comprehensive Cancer Center. "All of us in the field will be eagerly following this elegant work, which involves combinations that would uniquely harness previously untapped properties of the human immune system, and accompanied by innovative translational science that should yield greater understanding of immune responses to solid tumors."
Dr. Kalinski has spent the last 15 years developing a unique approach to cancer immunotherapy, or cancer treatment strategies that engage the immune system — first as a faculty member at University of Pittsburgh Medical Center (UPMC), and more recently at Roswell Park.
From Beartrap's earlier post:
"Dr. Kalinski and colleagues have built a compelling case in support of their out-of-the-box approach to cancer immunotherapy," says Kunle Odunsi, MD, PhD, FRCOG, FACOG, Deputy Director and Executive Director of the Center for Immunotherapy at Roswell Park Comprehensive Cancer Center. "All of us in the field will be eagerly following this elegant work, which involves combinations that would uniquely harness previously untapped properties of the human immune system, and accompanied by innovative translational science that should yield greater understanding of immune responses to solid tumors."
Dr. Kalinski has spent the last 15 years developing a unique approach to cancer immunotherapy, or cancer treatment strategies that engage the immune system — first as a faculty member at University of Pittsburgh Medical Center (UPMC), and more recently at Roswell Park.