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Maybe Tomorrow ??
Thanks erdoc1958
If this is the case, 0.80 may be possible!
MERS Coronavirus: Tracking the Outbreak
http://abcnews.go.com/blogs/health/2013/05/30/mers-coronavirus-tracking-the-outbreak/
The ABC News medical team reports on the outbreak of a novel virus as it unfolds.
Virus Slams Saudi Arabia; Travelers Warned?June 6 Katie Moisse (@katiemoisse)
Another person has died from the MERS coronavirus in Saudi Arabia, bringing the death toll to 31.
At least 55 people in eight countries have contracted the virus, according to the U.S. Centers for Disease Control and Prevention. Saudi Arabia has been hit hardest with 40 cases, 25 of them fatal.
Health officials are still searching for the source of the outbreak, which began in April 2012. All of the cases have ties to the Middle East, according to the World Health Organization.
Learn More About the MERS Coronovirus and How You Can Protect Yourself
Anyone traveling to the Middle East is encouraged to avoid close contact with people who look sick, wash hands thoroughly and often, and avoid undercooked meats as well as raw, unpeeled fruits and vegetables and unpurified water.
People who develop respiratory symptoms after visiting the Middle East are urged to cover their mouths during coughs and sneezes and seek immediate medical attention, which could result in a period of isolation if tests for the virus come back positive.
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Saudi Teen Contracts Deadly Virus?June 5 Katie Moisse (@katiemoisse)
A 14-year-old Saudi girl is the latest victim of the MERS coronavirus spreading through the Middle East and parts of Europe, the World Health Organization said today.
The girl, who suffered from underlying medical conditions, developed symptoms of the virus one week ago, according to the agency. She is said to be in stable condition.
At least 54 people have contracted the virus, which emerged in April 2012. Thirty people have died.
Learn More About the History of the MERS Coronavirus
The median age of patients is 56 years, according to the latest data from WHO, which does not include the 14-year-old girl. Many of the patients had underlying medical conditions that may have made them more vulnerable.
Image credit: Andrew Lynch, ABC News
The Search for Clues in Clusters?June 4 Katie Moisse (@katiemoisse)
At least 54 people have contracted the MERS coronavirus since April 2012, according to health officials who are looking for clues in seven disease clusters.
The first cluster of two cases occurred near Amman, Jordan, in April 2012, according to the U.S. Centers for Disease Control and Prevention. The second cluster occurred six months later in Saudi Arabia, where three family members tested positive for the virus. Two of them died.
Learn More About the MERS Coronovirus and How You Can Protect Yourself
Since February 2013, five more clusters have been reported in the U.K., France, Tunisia and Saudi Arabia again. The largest cluster of 23 cases has been linked to a Saudi health care facility, according to the CDC. Eleven people in that cluster have died.
The clusters provide evidence of human-to-human transmission, according to investigators who are still scrambling to find the source of the outbreak. All of the cases have ties to the Middle East, according to the World Health Organization.
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MERS Coronavirus Cases, Fatalities Mount?June 3 Katie Moisse (@katiemoisse)
Eight countries have reported MERS coronavirus infections as the number of cases and fatalities continues to mount. Italy confirmed its first case Saturday as a 45-year-old man who had recently traveled to Jordan, and Saudi Arabia reported three more deaths Sunday. All of the cases have ties to the Middle East, according to the World Health Organization.
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Three More Deaths in Saudi Arabia?June 2 Katie Moisse (@katiemoisse)
A new virus is spreading in the Middle East and parts of Europe. (Image credit: Reuters)
Saudi health officials say three more people have died from the MERS coronavirus, bringing the death toll in Saudi Arabia to 24. The country has seen the highest number of MERS cases since the outbreak started last year, with 38 known infections.
Infections have also emerged in Jordan, Qatar, the United Arab Emirates, Tunisia, Germany, the United Kingdom, France and Italy. All of the cases have ties to the Middle East, according to the World Health Organization.
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Virus Lands in Italy?June 1 Katie Moisse (@katiemoisse)
Italian health officials today confirmed the country’s first case of the MERS coronavirus, the Associated Press reported.
The patient, a 45-year-old man, is said to be on good condition after receiving treatment at a hospital in Tuscany, according to the AP. He reportedly developed symptoms of the virus after a 40-day visit to Jordan.
Infections have also emerged in Saudi Arabia, Jordan, Qatar, the United Arab Emirates, Tunisia, Germany, the United Kingdom and France. All of the cases have ties to the Middle East, according to the World Health Organization.
=======================================================================
Worry Grows Over ‘Superspreaders’?May 31 Richard Besser (@DrRichardBesser)
The MERS coronavirus has yet to surface in the United States, but experts say it’s “only a plane ride away.”
“It would be easy for this to be imported to this country,” said Dr. Tom Frieden, director of the U.S. Centers for Disease Control and Prevention. “CDC works 24/7 to track infections around the world because we are all connected by the air we breathe.”
Full Coverage of the MERS Coronavirus Outbreak
Frieden said he’s particularly worried about “superspreaders,” people who can pass viruses more readily than others. The 2003 SARS outbreak was driven by a small group of superspreaders, including the initial case in Hong Kong, and a couple who travelled to Toronto.
SARS sickened more than 8,000 people, killing 774 of them. The virus vanished in 2004, probably because non-superspreaders proved very ineffective at spreading the disease.
So far, at least 50 people have contracted MERS – the Middle East respiratory syndrome – and at least 30 of them have died. And while the virus seems to be spreading more slowly than SARS, there’s still the potential for superspreaders to ramp up the numbers.
“It’s only in the past month or two that it’s begun to look a lot more like SARS, and that’s why we’re more concerned now,” said Frieden, adding that Americans who have traveled to the Middle East should tell their doctors if they develop flu-like symptoms so they can be isolated and treated.
“Our job is to worry about things that might harm Americans so that Americans don’t have to worry themselves,” he said. “What we’re doing is working 24/7 to track it, to figure out where it is, how it’s spreading and how to make sure that we can stop it.”
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Death Toll Growing?May 30 Katie Moisse (@KatieMoisse)
A new virus spreading through the Middle East has claimed three more lives, according to Saudi health officials, bringing the death toll to 30.
At least 50 people have been sickened by the virus, newly-dubbed MERS-CoV for “Middle East respiratory syndrome coronavirus.” The majority of cases have clustered in Saudi Arabia. But infections have also emerged in Jordan, Qatar, the United Arab Emirates, Tunisia, Germany, the United Kingdom and France.
All of the cases have ties to the Middle East, according to the World Health Organization.
A Frenchman, who became ill after travelling to Dubai, died earlier this week roughly one month after being hospitalized with respiratory symptoms. His roommate at the hospital also contracted the virus, reaffirming suspicions that MERS-CoV can be passed from person-to-person.
Frenchman Dies From SARS-Like Virus
The virus has also spread through a health care facility Al-Ahsa, Saudi Arabia, where at least 22 patients have been sickened and 10 have died. In light of such cases, doctors on Wednesday recommended quarantining patients for at least 12 days.
Until recently, MERS-CoV was known widely as the “SARS-like virus” because of its semblance to the deadly SARS virus, which a decade ago sickened more than 8,000 people and killed 774. But experts caution that while both viruses can cause pneumonia and organ failure, MERS-CoV appears to spread less readily than SARS — so far.
=======================================================================
Dengue fever cases surge to 9000 in Singapore
http://post.jagran.com/dengue-fever-cases-surge-to-9000-in-singapore-1370961600
Singapore: Singapore is telling doctors to be more vigilant against dengue fever as the mosquito-borne disease surges this year. More than 9,000 cases and two deaths since January have been reported.
The illnesses counted so far in 2013 are already twice the total for all of last year.
Singapore's Health Ministry said in a statement that it has alerted clinics where dengue cases have spiked and has advised all medical practitioners about the early diagnosis and close monitoring of patients.
Dengue fever, spread by the Aedes aegypti mosquito, is common in Asia and Latin America. Symptoms include high fever, joint pains and nausea, but in severe cases, it can lead to internal bleeding, liver enlargement, circulatory shutdown and death.
Authorities say they're taking other measures such as increasing insecticide fumigation and sending officers to inspect locations where mosquitoes might breed. Public awareness campaigns are also being planned, including an online reality show focusing on environmental officers on anti-dengue patrols.
Singapore imposes tough penalties on residents whose homes are found to be mosquito breeding areas. Offenders can be fined and jailed three months. Singapore's worst dengue outbreak in recent years was in 2005, when nearly 14,000 cases and 25 deaths were reported. - See more at: http://post.jagran.com/dengue-fever-cases-surge-to-9000-in-singapore-1370961600#sthash.UOnC6ZPy.dpuf
For Alan, register to his website or email him.
For the second question email Dr. Seymour.
FN
I am looking for those 2 days:
NNVC success!
Seeing you in Hawaii !!!!
FN
the volume is already at 117.435 at 0.70
I have a feeling that this day is going to be a very good day for NNVC and these shareholders!!
FN
The Dane
I just woke up. (Los Angeles time).
What a better way to start my day.
This is a fantastic news. NNVC is now moving quickly!
And as Weedie says: We have the cides.
Forza NNVC!!!
FN
I agreed with you.
FN
Oh well!!
I know mine was delated too!!
This means that if you have a dream you want to realize, you can realize it.
Or maybe I don't understand English.
I never said "Dream it, and it will come'
What I meant is that every large business have started with a dream.
And for NNVC this whole thing was started with a dream and a mouse.
hope you understand it.
FN
Ho yes veal is tender and tasty!
Piccata limone
Milanese
Amatriciana
Boscaiola
Etc ......
Thanks Weedie
I love your positiveness and your kindness !!
We will meet in Hawaii !
FN
Amen to the beef!!
You don't get it !
leifsmith
I am sorry, I was telling you that you didn't make any mistake, and it look like that the person you were apologizing to was the same one you wrote your 1 first message.
Any way thank you for your great posts.
I hope one day we can meet with all the NNVC supporters.
FN
Hey Weedie!
How are you?
No, he doesn't use Dr Feelgood any more!
Year! Some people are using different identities on this board!
No, you were writing to the same person.
Yes, and it is very suitable.
If you can dream it, you can do it. Always remember that this whole thing was started with a dream and a mouse.
And as said Charles de Gaulle:
For glory gives herself only to those who have always dreamed of her.
Nothing great will ever be achieved without great men, and men are great only if they are determined to be so.
Yes, and from the FDA website:
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/ucm128291.htm
Fast Track, Accelerated Approval and Priority Review
Accelerating Availability of New Drugs for Patients with Serious Diseases
Speeding the development and availability of drugs that treat serious diseases are in everyone's interest, especially when the drugs are the first available treatment or have advantages over existing treatments. The Food and Drug Administration (FDA) has developed three distinct and successful approaches to making such drugs available as rapidly as possible: Priority Review, Accelerated Approval, and Fast Track. Because each of these approaches implies speed, there can be confusion about the specific meaning of each and the distinctions among them.
The following summary describes each element, how they differ, and how they complement each other.
Fast Track
Accelerated Approval
Priority Review
Comparison of Approval Times for Priority and Standard Review Drugs between 1993 and 2003
Dr. Seymour email May 29
Dear Dr Seymour,
Thank you for replying my emails.
I have an other question:
According to the FDA Approval Process, it could take:
1 year for phase l
2 years for phase ll
3 years for phase lll
plus 1-2 years to complete the review process and approve a drug.
Is it the case for us?
Are we going to wait an other 8 years before to be on the market?
Lorenzo
Subject: Re: FDA
From: drgeno@mac.com
Date: Wed, 29 May 2013 16:49:30 -0400
To: lorenzo_manaigo@hotmail.com
2 weeks for Phase I and 2 weeks for phase IIa
We should get breakthrough drug designation which could give approval next year
Those numbers you quoted were either for cancer drugs or relatively ineffective drugs like TamiFlu that need large trials that take years.
Eugene Seymour, MD MPH
Chief Executive Officer
NanoViricides, Inc
310-486-5677
Sent from my iPad
Great!
leifsmith Than you for the info.
FN
I am following NNVC for several years.
I have no doubt about their success.
It is quite normal that the wait is long.
Create a business takes time.
I do not know anyone who realizes a multi million dollar enterprise overnight!
This company has created a system to destroy viruses without leaving negative consequences on the patient.
They are building a facility to work on humans.
They do everything that the FDA asked them.
They have almost everything to succeed.
Of course everyone has their opinions, but your comments amuse me.
I hope to meet you in Hawaii, and toast to our disagreement.
To NNVC and anybody on this board!!!
FN
Yes it can take years for ineffective drugs but not for NNVC!
It's my understanding that NNVC will pass the FDA very quickly.
Please read:
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/ucm128291.htm
Fast Track, Accelerated Approval and Priority Review
Accelerating Availability of New Drugs for Patients with Serious Diseases
Speeding the development and availability of drugs that treat serious diseases are in everyone's interest, especially when the drugs are the first available treatment or have advantages over existing treatments. The Food and Drug Administration (FDA) has developed three distinct and successful approaches to making such drugs available as rapidly as possible: Priority Review, Accelerated Approval, and Fast Track. Because each of these approaches implies speed, there can be confusion about the specific meaning of each and the distinctions among them.
The following summary describes each element, how they differ, and how they complement each other.
Fast Track?Accelerated Approval?Priority Review?Comparison of Approval Times for Priority and Standard Review Drugs between 1993 and 2003
Fast Track
Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious diseases.
Determining whether a disease is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one. AIDS, Alzheimer’s, heart failure and cancer are obvious examples of serious diseases. However, diseases such as epilepsy, depression and diabetes are also considered to be serious diseases.
Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially superior to existing therapy.
Any drug being developed to treat or prevent a disease with no current therapy obviously is directed at an unmet need. If there are existing therapies, a fast track drug must show some advantage over available treatment, such as:
• Showing superior effectiveness
• Avoiding serious side effects of an available treatment
• Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome
• Decreasing a clinically significant toxicity of an accepted treatment
A drug that receives Fast Track designation is eligible for some or all of the following:
• More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
• More frequent written correspondence from FDA about such things as the design of the proposed clinical trials
• Eligibility for Accelerated Approval, i.e., approval on an effect on a surrogate, or substitute endpoint reasonably likely to predict clinical benefit
• Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA, and
• Dispute resolution if the drug company is not satisfied with an FDA decision not to grant Fast Track status.
In addition, most drugs that are eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review. Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within?sixty days based on whether the drug fills an unmet medical need in a serious disease.
Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
Accelerated Approval
When studying a new drug, it can take a long time - sometimes many years - to learn whether a drug actually provides real improvement for patients – such as living longer or feeling better. This real improvement is known as a “clinical outcome.” Mindful of the fact that obtaining data on clinical outcomes can take a long time, in 1992 FDA instituted the Accelerated Approval regulation, allowing earlier approval of drugs to treat serious diseases, and that fill an unmet medical need based on a surrogate endpoint.
A surrogate endpoint is a marker - a laboratory measurement, or physical sign - that is used in clinical trials as an indirect or substitute measurement that represents a clinically meaningful outcome, such as survival or symptom improvement. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.
Approval of a drug based on such endpoints is given on the condition that post marketing clinical trials verify the anticipated clinical benefit.
The FDA bases its decision on whether to accept the proposed surrogate endpoint on the scientific support for that endpoint. The studies that demonstrate the effect of the drug on the surrogate endpoint must be “adequate and well controlled” studies, the only basis under law, for a finding that a drug is effective.
Use of a surrogate can save valuable time in the drug approval process. For example, instead of having to wait to learn if a drug actually can extend the survival of cancer patients, the FDA might now approve a drug based on evidence that the drug shrinks tumors because tumor shrinkage is considered reasonably likely to predict a real clinical benefit. In this example, an approval based upon tumor shrinkage can occur far sooner than waiting to learn whether patients actually lived longer. The drug company will still need to conduct studies to confirm that tumor shrinkage actually does predict that patients will live longer. These studies are known as phase 4 confirmatory trials.
If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit for patients, FDA has regulatory procedures in place that could lead to removing the drug from the market.
Priority Review
Prior to approval, each drug marketed in the United States must go through a detailed FDA review process. In 1992, under the Prescription Drug User Act (PDUFA), FDA agreed to specific goals for improving the drug review time and created a two-tiered system of review times – Standard Review and Priority Review.
Standard Review is applied to a drug that offers at most, only minor improvement over existing marketed therapies. The 2002 amendments to PDUFA set a goal that a Standard Review of a new drug application be accomplished within a ten-month time frame.
A Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. A Priority Review means that the time it takes FDA to review a new drug application is reduced. The goal for completing a Priority Review is six months.
Priority Review status can apply both to drugs that are used to treat serious diseases and to drugs for less serious illnesses. The FDA goal for reviewing a drug with Priority Review status is six months.
The distinction between priority and standard review times is that additional FDA attention and resources will be directed to drugs that have the potential to provide significant advances in treatment.?Such advances can be demonstrated by, for example:
• evidence of increased effectiveness in treatment, prevention, or diagnosis of disease;
• elimination or substantial reduction of a treatment-limiting drug reaction;
• documented enhancement of patient willingness or ability to take the drug according to the required schedule and dose; or
• evidence of safety and effectiveness in a new subpopulation, such as children.
A request for Priority Review must be made by the drug company. It does not affect the length of the clinical trial period. FDA determines within 45 days of the drug company’s request whether a Priority or Standard Review designation will be assigned. Designation of a drug as “Priority” does not alter the scientific/medical standard for approval or the quality of evidence necessary.
SUMMARY
Fast Track, Accelerated Approval and Priority Review are approaches that are intended to make therapeutically important drugs available at an earlier time. They do not compromise the standards for the safety and effectiveness of the drugs that become available through this process.
These revitalized FDA drug review approaches have yielded tangible results in bringing safe and effective drugs to patients with serious diseases more quickly. For example, since 1996, 68 drugs for cancer therapies have received priority review and approval.
FDA reviewed Gleevec, a treatment for chronic myeloid leukemia, in four months. Shortened review times have also brought promising treatments to patients with HIV/AIDS more quickly. Kaletra for the treatment of HIV/AIDS was reviewed and approved in 3.5 months. Pegasys, a combination product for the treatment of Hepatitis C was approved for marketing in 4 months.
The table below illustrates the improvement in FDA review times in the years between 1993 to 2003. The median time required to review a priority review drug was reduced from 13.9 months to 6.7 months.
Fast Track, Accelerated Approval, and Priority Review have evolved over time. FDA has been vigilant in assuring that reducing the time necessary for drug development has not compromised the safety and effectiveness of drugs for patients with serious diseases.
Cross our fingers!
There are too many people of any age who suffer and die. and this is unacceptable.
FN
It's on the news! It 's the earliest and the most intense flue season in a decade, This morning the CBC said an alarming 41 state have Widespread influenza activity!
That's up 21% of 2 weeks ago. Already 18 children has died and those number will continue to rise. Near the Great Lakes nearly 60% of those who was checked, tested positive for the flue, That's nearly double the usual number! Typical Flue seasons begin around now after the Holidays , but this year it's started in October !
FN
Yes but think about the billions of dollars that the health industry make on sick people.
Like the flue vaccine for example.
It is a huge busyness.
Any way NNVC will be also a great busyness!
So! Go NNVC!!
FN
Yes Echo,
I hope that my wife is wrong when she said that the government want people to be sick for the heath business.
This is really bad!
Why the Flu Vaccine Doesn't Work
The Centers for Disease Control (CDC) is looking at whether or not the flu vaccine is effective. Preliminary results indicate you'll get just as sick (with colds, flu, flu-like illnesses) if you got the vaccine than if you didn't. Why doesn't the vaccine work? In order to understand the answer, you'll need to understand some specifics about the flu vaccine and a bit about how immunity works.
http://chemistry.about.com/cs/howthingswork/a/aa011604a.htm
Yes Weedie!
These statistics are alarming!
And it is only the beginning!
2012-2013 Influenza Season Week 51 ending December 22, 2012
Interesting statistics on influenza 2013:
http://www.cdc.gov/flu/weekly/weeklyarchives2012-2013/weekly51.htm
Merry Christmas and Happy New Year to you all!
FN