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NTAP Approval
This was posted today in the CMS FY 2023 Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Final Rule — CMS-1771-F Aug 01, 2022 Medicare Parts A & B.
"Applications for NTAP Approved for FY 2023"
"CMS also conditionally approved one technology under the alternative pathway for products that received FDA Qualified Infectious Disease Product (QIDP) designation that otherwise meets the alternative pathway criteria, but has not yet received FDA approval."
Maybe this is the NTAP approval for Defencath.
Ok. I am sorry I posted in the first place. Done with this for now. Will just sit back and wait for TLD, hoping to make enough money to be more financially comfortable.
Let me be a bit more clear, with a couple edits:
I stand corrected. In her most recent, 2/15/22, grand rounds presentation, 25% five-year survival in the DCVax-L alone patients is far less than the 50% continuing survival in the DCVax-L + adjuvant patients. However, this is relative to approximately 5% three-year survival with current SOC. TLD from the recently completed phase III trial is likely to be very impressive and undoubtedly DCVax-L will be approved and quickly become SOC. The possibility for curative efficacy in combination with adjuvants is very exciting.
I stand corrected. In her most recent grand rounds presentation, 25% five-year survival in the DCVax-L alone patients is far less than the 50% continuing survival in the DCVax-L + adjuvant patients. However, this is relative to approximately 5% three-year survival with current SOC. TLD from the current phase III trial is likely to be very impressive and undoubtedly DCVax-L will be approved and quickly become SOC. The possibility for curative efficacy in combination with adjuvants is very exciting.
Will TLD from phase III trial be enough?
It is clear from Dr. Liau's recent grand rounds presentation that TLD from the phase III trial with DCVax-L alone will not show blockbuster efficacy. More curative efficacy will require combination with agents to block checkpoint inhibition and reduce the effect of immunosuppressive cells entering the tumor following DCVax-L treatment. However, DCVax-L will undoubtedly be an essential part of whatever new brain cancer immunotherapy is approved.
This leads to a question of how much increase in NWBO stock price we can expect upon publication of TLD from the current phase III trial. Will a substantial increase in NWBO value require approval based on the results of combination phase III trials years from now, or will the slight increase in survival expected in TLD from the recently completed phase III trial provide for a more immediate substantial increase in the value of NWBO stock?
On another point, Dr. Liau made an interesting comment regarding FDA acceptance of the revised SAP. She said that although the European and Canadian regulatory agencies have been more transparent regarding this, approval from the FDA may be construed from the fact that they did not respond to the request for at least 30 days. This sounds like the FDA has not formally approved the new SAP and that is why NWBO has not yet modified the Clinical Trial web site in this regard.
Am I misreading the list of inspection approval dates at the link you posted, or are almost all of the MHRA GMP certifications granted within a week of the inspection? If that is the case, and Sawston was inspected back in October, is it likely that there is some delay in the certification of Sawston?
There is no new information about the clinical trial. She states: "Because datalock was just recently completed at the time of this writing, the data remain blinded for this trial."
It is most certainly true that the research funds from the cancer moonshot went/go to labs with already well-funded cancer research projects. It began with a group of NIH-funded cancer research scientists meeting to decide how the money should be spent. That meeting resulted in funding opportunity announcements to apply for increased funding of already funded projects, without opportunity for new innovative project funding beyond research ideas designated by the group. I know of a number of cancer researchers with innovative ideas that could not apply for moonshot funds because no category for their ideas was announced. There was no announcement of funds for new, currently unfunded, innovative ideas. Somehow, the group of senior established researchers decided the funds should be distributed to projects that were already being funded i.e., the projects that have been ongoing for decades without resulting in a substantial reduction in the morbidity and mortality due to cancer. What is needed, in addition to continued work on established projects, is subtantially increased funding for new innovative approaches. Certainly at least half of the applications to the NIH for cancer research funding from the very qualified highly trained academic workforce in this country should be funded. However, less than 15% of those grant applications are funded, and the majority of those funds go to long established labs rather than new innovative researchers.
The problem with the "Cancer Moonshot" is that the research funds are distributed by the "good old boys" to the "good old boys". Very little of the funding is given to new innovative ideas. It is mostly spent on incrementally advancing the same ideas in the same labs that have failed to significantly advance cancer therapy for decades.
"Our phase III study which reached 298 events the end of April and is now in the data lock analysis stage and I can't predict exactly when it will end because its out of my hands its being run by the CROs and there are all kinds of uncertainties all over the place right now, but anyway its all moving forward rapidly"
Translation: One of these days the CROs will tell Geert the result of the trial. Within a few days of that, Geert will tell us.
That's what our immune system is, "a swarm of hunter-killer cells personalized to the individual". Multikine is as good a way as any to overcome a tumor's suppression of this "swarm" and stimulate it to attack the cancer. This is a very exciting trial of the idea that the immune system can be induced to reduce or eliminate tumors and likely establish an immune memory to guard against recurrence. The fact that it has gone on this long without reaching the endpoint is very encouraging and every day is more exciting than the last, especially for the trial volunteers who are benefitting. I doubled my position at 5.41 pps and will again when funds become available.
What do you mean by "no comparison"? Have you read these two papers?
Malard B, Lambert C, Kellum JA: In vitro comparison of the adsorption of inflammatory mediators by blood purification devices. Intensive Care Med Exp 2018; 6: 12.
Malard et al. Clinical Utility of Extracorporeal Cytokine Hemoadsorption Therapy: A Literature Review Intensive Care Medicine Experimental (2018) 6:12
https://doi.org/10.1186/s40635-018-0177-2
Not Pearsby. Been in and out of Cytosorb since MSBT days. Slightly in now and looking to get in deeper after cashing out some CRMD profits. So, your argument regarding competition from oXiris is that upon FDA approval the Cytosorb filter will beat the oXiris filter to the US market?
How about oXiris? Recent literature suggests cytokine removal by the oXiris filter is at least equivalent to Cytosorb and the oXiris filter removes endotoxin. Do you know what is better about Cytosorb relative to Baxter's oXiris?
Over 200,000 people in the U.S. die each year from sepsis. So, if the FDA waits two more years to approve the use of Cytosorbent's filters in this country, they are preventing about half a million people from using a life saving therapy. Way to go FDA!
P3 will likely succeed.
There is much to indicate that the phase III trial results will lead to an FDA decision to permit marketing of Multikine including: extensive preclinical experimentation demonstrating substantial efficacy in mouse models of human head and neck cancer, phase I and II human clinical trials indicating safety and efficacy, and a recent FDA examination of the phase III trial resulting in a determination that it has been safe and should be allowed to proceed toward an anticipated successful conclusion.
Either:
1. Ergomed does not want to wager with its pay check.
2. Ergomed is gettin' while the gettin' is good.
Perhaps we can make the assumption that "not enough are dying fast enough BECAUSE multikine" based on the preclinical, phase I and phase II results. After all, that is why this proceeded to phase III. It is very encouraging that so many volunteers have been treated with multikine and the trial has continued to completion without incident. Had there been any significant safety issues, this trial would have been stopped long ago. It is very likely that this trial will result in at least the 10% improvement over standard of care. The only thing that could interfere with application of this therapy following conclusion of this trial would be development and proof of some superior therapy. That is quite unlikely at this point. Multikine is likely to be added to the standard of care for head and neck cancer sometime next year and will probably be used in additional cancers as well.
The $8 agreement remains in effect into 2021, so it is certainly going to trigger. Maybe it is being held off until the next major stimulus. In which case this is a great time to buy.
Nice analysis. Obviously, from this point on the longer we wait for trial results the greater the benefit of Multikine therapy. Given the results of the Phase II trial and all of the exciting research results regarding the efficacy of anticancer immunotherapy, it is very likely that the results of the Phase III trial will be substantially better than the required 10% increase in survival. In the meantime, we can expect a steady increase increase in pps toward May or June, followed by a hopefully significant increase when the arbitration is concluded.
Delivery of multiple immune stimulating molecules to the tumor microenvironment with reduced systemic toxicity is very exciting. Combined with current standard of care treatments that release tumor associated antigens this therapy will certainly result in increased efficacy!
Right on. That is definately what this is all about!
This halt is likely about the arbitration. It would seem to be halting too long to be about the FDA response. Besides the FDA response is not due for a couple more weeks. Also, the ask jumping to over two bucks just before the halt looks positive.
Can anyone suggest any "good" reason for this reverse split happening before the FDA decision on the trial hold that is due in about two weeks?