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I heard and read the same points you’re making. I expecting MIA approval in early Q1 and hoping MAA submission by early Q2.
The MIA approval is not required for the MAA submission, but I think NWBO wants to ensure that the manufacturing process, including Flaskworks, is approved so that it can be part of the application. Clearly the manufacturing process for DCVAX is much more complex than the standard drug, which is why I think they are waiting for MIA approval first.
Quality part of MA dossier
3.2.S.2 Manufacture
– 3.2.S.2.1 Manufacturer(s)
– 3.2.S.2.2 Description of Manufacturing Process and Process Controls – 3.2.S.2.3 Control of Materials
– 3.2.S.2.4 Controls of Critical Steps and Intermediates
– 3.2.S.2.5 Process Validation and/or Evaluation
– 3.2.S.2.6 Manufacturing Process Development
I agree and while the company was hoping to have the MIA approved by year end, I think it is likely to happen in January based on their update. Hopefully the MAA submission will follow shortly thereafter in the Q1 timeframe. These two milestones along with manufacturing guidance outside of the UK is what I was looking for and received.
Why won’t they lay out the milestones with estimated timelines
They didn’t have TLD along with a JA and an MIA submission in the past. Laying out a plan of next steps and answering questions is not a material event. Anyway, I hope we get some guidance.
I don’t disagree with you, but the ASM should also be opportunity for the company's directors to share their vision of the company's upcoming plans and strategy with the shareholders. It should also be an opportunity for shareholders to ask questions and interact with the company’s directors. It’s not just about the voting. I’d like to get some of my questions answered that I submitted, but am not holding my breath.
It would be nice to know that everything is progressing as it should as you indicated. What is the status of the MIA? Are there issues that need to be resolved? What is the new ETA? When will they submit the MAA? What are the next set of milestones?
Some questions.
1. What is the status of MIA? The hope was that this would be completed by year-end. Are there issues or is it just taking a bit longer than expected?
2. What is the status of the MAA submission. NWBO indicated in the July 6th press release that a manufacturing license is separate from any regulatory decision about approval of DCVax-L itself and that the Company has not to date submitted an application for commercial approval of DCVax-L.
3. What is the execution strategy now that TLD, JA and quiet period are over?
4. What are the manufacturing plans and next steps in the US?
Well, I hope these interim results get published and a PR is issued in the very near future. Extremely promising.
Do you think Merck and / or NWBO issue a PR?
Thanks. I didn’t know if the 96 weeks included the already completed 48 weeks, and when the 48 week mark was reached. So it sounds like the 48 week mark was reached in June and open label will continue another 96 weeks from that point.
Can anyone comment on when the the 96 weeks will be reached for the open-label extension?
The open-label extension study ATTENTION-AD will continue to follow participants over 96 weeks
Not sure about the media policies, but the OTCQX market is the top OTC tier, with the most stringent entry requirements. Over 400 companies trade on the OTCQX including Roche.
I’m wondering if uplisting to the OTCQX market makes sense at this point. It may provide access to a much larger audience of institutional and retail investors. It would also demonstrate that NWBO meets the strict guidelines for listing, transparency and governance standards. Just a thought since uplisting to a major exchange is going to take some time. Could be a positive step forward to getting back on the Nasdaq.
I’m in agreement. A plan is required before the ASM. I hope it’s associated with a JV, but not holding my breath. Over the next few weeks, I would be satisfied with MIA approval, MAA submission and an execution plan that includes their immediate intention to partner in order to provide the necessary financing and get uplisted.
They don’t need additional financing to make theses three milestones happen by the end of December. MIA should hopefully be obtained in the next two weeks. Same with MAA submission. Now all I’m asking for is a strategy, which hopefully will come in the way of a JV, but at the very least a set of near future milestones.
Bottom line is that every vote matters. I’ve been invested for about 10 years and want this saga to come to an end with a JV, and an approval within the next 6 months. I will vote NO to an increase if they don’t accomplish the following:
1. MIA approval
2. MAA submission
3. Provide an execution strategy now that TLD, JA and quiet period are behind us.
“And every absence of vote is a NO vote.”
I don’t believe an absence of vote is a NO vote. If a shareholder does not vote, these votes are not cast either for, or against, and are not counted in the final tally. Therefore, it’s important that everyone vote.
Thank you Thermo, BIO and ATL for taking the time to respond. I’ve been invested in NWBO for a long time and continue to accumulate. It’s been a long journey and everything is looking very positive to me. Just trying to determine if there is anything that I’m missing.
GLTA and have a Happy Thanksgiving.
Is there any concern that Dr Liau has a patent pending for combo with dc? Could this impact future opportunities for NW?
Conflict of Interest Disclosures: Dr Liau reported serving on the board of directors of ClearPoint Neuro outside the submitted work and having a patent pending for combinations of inhibitors with dendric cell vaccines to treat cancer.
Very very long NWBO
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both North America and Europe. The Company has a broad platform technology for DCVax® dendritic cell-based vaccines. The Company’s lead program is a 331-patient Phase III trial of DCVax®-L for newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an “orphan disease.” This Phase III trial has been completed and top line data was presented by a key investigator at a recent scientific meeting. The Company also plans to pursue development of DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and plans to prepare for Phase II trials as resources permit. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania.
I am very long in NWBO but my concern is that while the DCVax-L activates the T cells, Linda’s current findings indicate that it’s more effective when combined with PD-1. Hopefully DCVax-L alone will be effective enough for approval.
This is a great comparison and demonstrates why DCVax should be approved.
I agree this seems unprofessional and also makes me uncomfortable, but who else is going to host NWBO at the point. The host also mentioned that Les is his friend, which may have something to do with it.
On February 2nd she stated they were in the middle of the multi-month process. That’s over 3 months ago. So presumably they have been working on these two activities for at least 5 months so far. Something has to give really soon.
It would appear that the initial publication was July 2018 and now it is April 2019. This could be due to patients living longer than they expected. See the project documentation.
Great Conference Call
No issues with Safety
People lining up to get into the trial. Unfortunately only 36 in Phase I and 24 in Phase II
Much more to come in the next couple of months
Thanks for setting me straight. I was in fact looking at the wrong agenda. So there is still hope for a PR either today or tomorrow.
Yes, but that seems to be an old version of the agenda
Antibody Engineering Agenda
This may have already been confirmed, but I do not see Peregrine on the agenda for tomorrow
http://www.ibclifesciences.com/antibodyeng/agenda.xml
I believe PPHM also had to pay 1M in interest. So the total they had to repay was ~16M
I am also a long-term shareholder and avid reader of this board, but don't post that often. Like others, I lost a signficant amount of potential profit yesterday. I have always believed in the science, which is why I have stuck it out so long, and have not sold. I too greatly appreciate the insight and efforts from FTM, RR, KT, Bungler, EZLibra, TekNuLoof, cjgaddy, entdoc, jakedogman1,asmarterwooki, etc. I agree that a private board would help and am willing to help out however possible.
Best to all the longs.
Regards,
Chris
I've been invested in PPHM for about 7 years, and this is the longest silent period that I can remember. It's been over two months without a PR of any substance. Even last year when they reported earning after hours on Friday, March 11th, they had PRs everyday following up to that event. The # of near-term milestones has never been greater, so I just don't understand the silence, but I'm sure we will find out tomorrow.
King Interview for the upcoming OneMed Conference http://www.onemedplace.com/database/list/cid/344
Apologies if this was already posted. Nice article from Science Mag.
http://www.stanford.edu/~ruthersh/editor.pdf
When viruses hijack intracellular machinery in
order to replicate, they alter the infected host
cells, making them more visible to the immune
system or to specific drugs. Phosphatidylserine is
an abundant phospholipid that is actively maintained
on the inner side of the plasma membrane,
but under certain conditions the asymmetrical
localization of this and other aminophospholipids
is lost. Soares et al. reasoned that infected cells
might also expose hidden lipids, which could be
used as drug targets. Indeed, they found that four
different viruses, including influenza A, induced
infected cells to expose phosphatidylserine on
their outer surfaces, which could then be recognized
by the mouse/human chimeric antibody
bavituximab. Animals that had been infected with lethal doses of Pichinde virus or cytomegalovirus
were saved by bavituximab treatment, which
caused cytotoxicity of virus-infected cells
Hopefully each of these events provide some key updates
Why are these events not being announced?
Dec9: IBC ‘Antibody Therapeutics’, San Diego http://tinyurl.com/6gf729
…Dr.Thorpe, 9am: “Preclin. dev. of the Vascular Targeting Antibody, 1N11" [1N11=PGN635=fully-human Bavi]
Dec11: “31st San Antonio Breast Cancer Symposium” (SABCS) http://tinyurl.com/5wgbng
…Dr. R.Brekken (PPHM SRB) Poster #1034: “Selective Inhibition of VEGFR2 Activity with a Human Anti-VEGF Mab Decreases Tumor Growth & Macrophage Infiltration in an Orthotopic Model of Breast Cancer” [Fully-Human 2C3 = PGN311/Affitech]
No mention of the Affitech presentation today