CheckMate-816

It is still a long way to go till completion.
Estimated Primary Completion Date : May 8, 2023
Estimated Study Completion Date : November 8, 2028

?

What is the difference between Complete Response (CR) and pathologic complete response (pCR)?

CR does not mean the cancer is gone for good. pCR means a patient is cancer-free?

Thanks in advance.

Over the weekend, FDA Commissioner Stephen Hahn alarmed experts when, in an interview with the Financial Times, he suggested the regulatory body could approve a vaccine before Phase 3 trials are complete.

Yale study: Men and women may need different coronavirus treatment
https://www.chron.com/news/article/Yale-study-Men-and-women-may-need-different-15522162.php

Please reference the supporting data.

The U.S. Food and Drug Administration late Friday allowed the drug remdesivir to be used on all patients hospitalized with COVID-19, although no published research supports such widespread use.

Earlier this month, the Journal of the American Medical Association published a study of less severely ill hospitalized adults, showing that five days of treatment with remdesivir was better than standard care, though "the difference was of uncertain clinical importance."

"It seems to be a pattern of approval without science, without data, without evidence," said Dr. Eric Topol, vice president for research at Scripps Research in La Jolla, California and a national expert on the use of data in medical research.

The FDA uses that process to approve products that, based on scientific evidence, it is “reasonable to believe … may be effective.”

The similar case was with the FDA approval for AZN/MRK Olaparib in prostate cancer pts. The drug was approved even for patients who according to clinical trials results have shown no benefit whatsoever.

We need reliably treat the disease if we hope to contain it and go back to business/life as normal, or at least a new normal.
If COVID-19 vaccines as good as flu vaccines, it will change very little. It is absolutely vital to keep people out of ICU or hospitals in general.

The more I watch the Covid vaccine/treatment development the more I am convinced that there is very little understanding of the virus and we are for a very big surprise in the next 12 months. Hopefully, it is a positive one.

Patent existence is exactly to prevent others from using it. Nothing justifies patent violations under any circumstances.

Yes, COVID-19 is bad but cancers and other diseases are not any better. Why just kill all patents and life happily after using other people properties? It is alway easy to justify social justice but it is always detrimental to humanity.

The Guardian, 7/16/20

Coronavirus vaccine: Oxford team aim to start lab-controlled human trials.
Jenner Institute at Oxford looks to recruit healthy volunteers for controversial ‘challenge trial’

Stakes are going up. The losers will be devastated.

MRNA
-Head of operation WARP Speed, Dr. Slaoui, MRNA board member, was required to disclose and divest.
- Market Cap =$32.5B

As for Nobel Prizes, they lost a lot of their original value lately.

Asymptomatic patients among young patients will contribute to the "uninfected" patient group unless ALL pts will constantly tested for the disease.

miljenko,

Agree. The FDA criteria for the vaccine approval looks to me bogus. Asymptomatic patients among young patients will easily clear the FDA required threshold.

May be I am making prediction too early.

Based on the Oxford/AZN chimps vaccination results, Oxford vaccine will not prevent people from being coronavirus infected and still capable of spreading the disease but will substantially reduce COVID19 disease severity. However, Oxford vaccine at lease appears to be relatively safe.

My another thought about sizable side-effects of mRNA vaccines: it appears to me that mRNA vaccinated patients will have severe adverse reactions after being exposed to the virus.

Any comments?

From @chihawk blogger at Seeking Alpha website.

Is the below correct?

Making both T-cells and neutralizing antibodies does sound like a good goal. And memory T-cells do matter of course. But with an adenovirus vector vaccine, how can they tell if the T-cells are against the protein antigen or against the chimp virus vector? Traditionally neutralizing antibodies support the likelihood that memory T-cells and memory B-cells have been formed. Of course the antibodies themselves fade, but they are made by T-cells and B-cells. In preclinicals, Oxford showed good T-cell responses but some of the weakest ELISA numbers on antibodies. This seemed to support their ability to prevent disease but not to avoid infection in the monkeys. Now they are suggesting a similar result would be a sign of strength in humans? Is Oxford preparing to sell us new science July 20th?

NEJM's Moderna paper.

People do not read what they write. The example:

"VACCINE SAFETY
No serious adverse events were noted.

Few lines below:
Solicited systemic adverse events were more common after the second vaccination and occurred in 7 of 13 participants (54%) in the 25-µg group, all 15 in the 100-µg group, and all 14 in the 250-µg group, with 3 of those participants (21%) reporting one or more severe events."

<After the first injection of the coronavirus vaccine, all participants began developing antibodies by day 15. Following the second injection — at day 57 — all participants showed an average concentration of antibodies greater than that of recovered Covid-19 patients.

At day 43, the midsize dose generated 4.1 times the average concentration of antibodies seen in recovered Covid-19 patients.
At day 57, the average concentration of antibodies was 2.1 times higher in patients who received the coronavirus vaccine.


Following the second vaccination, patients who received the low- or midsize dose of the coronavirus vaccine also had responses from immune cells called T cells.

Now, Moderna is working to see if the immune responses are durableThree out of 14 patients in the high-dose tests experienced severe side effects following the coronavirus vaccine check...

Most side effects occurred after the second vaccination. In the low-dose group, 54% reported systemic side effects vs. all the patients in the midsize and high-dose groups.

CONCLUSIONS
The mRNA-1273 vaccine induced anti–SARS-CoV-2 immune responses [very questionable statement] in all participants, and no trial-limiting safety concerns were identified.>

There are three concerns:
1. Vaccination durability
2. Vaccination effectiveness. The presence of antibodies does not mean they are effective preventing and/or reducing the disease severity.
3. Long-time vaccine induced complications.

WOW. OGEN has 7 full-time employees...
I wonder, how soon will OGEN get $1B+ support for manufacturing infrastructure?

6 months and no clue where ENTA is going.

So far, ENTA's coronavirus efforts were very disappointed.

Researchers support use of doping agent for improving COVID-19 symptoms in severely ill patients
Erythropoietin (EPO) – a commonly used anemia medication can also be effective against COVID-19, pointed out new research. Keeping in mind the current therapeutic situation in COVID-19, any measure to improve disease course and outcome of seriously ill individuals is of utmost importance.

The experts at the Max Planck Institute of Experimental Medicine in Gottingen revealed that EPO could mitigate severe disease progression and protect infected patients from long-term neurological effects when the novel coronavirus attacks the brain.

https://www.ibtimes.com/coronavirus-treatment-drug-banned-sports-found-effective-fighting-covid-19-3006779

It is simple. Fed is the major securities buyer and it is not buying Biotech.

It is crazy. VXRT has just 14 full-time employees including a President, VPs Accounting, legal, Human resources, et.,
By the way, their vaccine is still in a Preclinical stage.

Well, Fed printing presses will save us from COVID-19 and everything else.

https://www.scmp.com/news/china/science/article/3089771/coronavirus-may-be-here-much-longer-due-rapid-mutations

Coronavirus may be here for much longer – due to rapid mutations

* Since January, the virus has gone through at least six major gene changes that boosted its ability to infect and evade the human immune system

* The US and Britain are the two major virus mutation hotbeds at the moment, say scientists

* These mutations were in a way similar to those that occurred in human immunodeficiency virus (HIV) and influenza, which dodge immune attack with fast mutation.

* But if the immunity was short-lived, the outbreak would return every year, said the researchers led by Professor Marc Lipsitch from the Harvard TH Chan School of Public Health in a paper published in Science magazine last month.

* A research team in Wuhan reported on Tuesday they failed to find long-lasting antibodies among medical workers exposed to the virus at the early stage of outbreak.

* They warned that humans might never develop immunity against Covid-19.

PS
The treatment is the key from this

Thanks for the reply.

A question

Scripps Research is developing treatment for Covid-19 using antibodies analyzed & selected from the recovered pts.

From almost 1,800 antibodies they had identified 3 most promising/potent antibodies against Covid-19 virus.

People developing Covid-19 vaccines telling us that their vaccines created antibodies as markers for effectiveness of their vaccines. Now the question:

Since there are so many antibodies, how do they know that the antibodies created by their vaccines are indeed effective against the virus?

Lately, I discovered that different non-scientific publications reported inaccurate data and data interpretations.

Another comment, antibodies are different executing different functions.

https://www.sciencedirect.com/science/article/pii/S1477893920302179

WHO stopped a Covid-19 trial.

https://www.telegraph.co.uk/news/2020/05/23/oxford-university-covid-19-vaccine-trial-has-50-per-cent-chance/

Good review of the Oxford vaccine development efforts and other events.

MRNA announcement was perfectly timed to the new offering.

I also understand that MRNA CEO is a heavy seller of the company shares.

Finally, the CEO does not guaranty the success but rather a great promise

Nobody yet developed a vaccine for any coronaviruses. Hopefully, someone succeeds soon.

jog,

with great respect, I would suggest you to review the Gates Foundations vaccine history.

"who ever wins the race, should be good for all of us."

Taking into account a possibility that no viable vaccine will be developed, with so generous reward and political pressure, there is a strong possibility that a very marginal vaccine will be selected without proper evaluation of its side-effects.

Spoke to my colleague in Easter Europe.

His entire family (3 generations) got COVID-19. They got from mild to severe forms of the disease. One single contact has made all sick. The virus is terribly contagious. Thanks God they all do very well.

I had a very interesting conversation about symptoms, treatment, drugs, and the disease statistic manipulation.

Agree that nursing home pts are the sickest of the elderly population.

I also think that Nursing homes pts neglect is another reason. Pts don't get timely care.


PS
Interesting article:

Influenza vaccination and respiratory virus interference among Department of Defense personnel during the 2017–2018 influenza season
https://www.sciencedirect.com/science/article/pii/S0264410X19313647?via%3Dihub#t0025

"Conclusions
Receipt of influenza vaccination was not associated with virus interference among our population. Examining virus interference by specific respiratory viruses showed mixed results. Vaccine derived virus interference was significantly associated with coronavirus and human metapneumovirus; however, significant protection with vaccination was associated not only with most influenza viruses, but also parainfluenza, RSV, and non-influenza virus coinfections.""

jog,

Thank you for the reply.

Let me please rephrase the question:

My am not interesting in high rates of spreading Covid-19 but rather in death rates of elderly pts in and outside nursing homes.

Why do nursing home Corona pts die at much higher rates than elderly corona pts living outside nursing homes?

It appears that nursing home population was devastated all around US and EU?
Why? What is so special about these places? Yes, their pts were elderly but 50%+ death rate is something special and greatly exceeds the elderly population death rate in general.

Any suggestion?

I don't care about antibodies. I will be happy when a number of new Covid-19 cases goes well down.

Note that famotidine is one of the main treatment COVID-19 drug in Japan, S. Korea and other Asian countries.
Japan indicated that the drug is much more effective at the early disease stages. This trial was for more advanced pts and still with very good results.

Let us look at somewhat reliable statistical numbers:

Deaths/1 Million population
Japan, S. Korea -- 5
Sweden -- 314
USA -- 238
Well, we ~ 48 times worse than the leading countries with reliable number.

Tot Cases/ 1 M pop
Japan -- 123, S. Korea -- 211
Sweden -- 2,502
USA -- 3,993
Again, these numbers is not in our favor. Even Sweden without ruining their economy is doing better us.

Looks like we have failed very badly. Our health system is exclusively for profit. Instead of treating with intention of curing pts and eradicating diseases, we are spending enormous amount of money and energy keeping pts alive for another month or two. Looks like our economy cannot afford it anymore.

The official COVID statistics in America incorporates lots of guesses.

The most accurate is the hospital admission rates.

Nobody knows the real numbers due to very limited testing. Nobody has any clue of COVID statistics for homeless, illegals, and people with mild symptoms.

America is not S. Korea, Israel, Taiwan, etc.,

By the way, COVID vaccine is good but if it will be as effective as seasonal flu, the nightmare will continue indefinitely. COVID is a viral infection and it must be killed.

The primary reason "Spanish Flu" disappeared, it was due to bacterial infection.