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Rethink it
UN: We Botched Response to the Ebola Outbreak
The Ebola outbreak already has killed 4,546 people in West Africa out of at least 9,191 cases. WHO says within two months, there could be new 10,000 cases of Ebola every week unless stronger measures to fight the outbreak are put into place.
Time to give Bavi a try ?
Maybe combining Bavi with one of the administered drugs would help the safety or efficacy of the application. I believe that pp is involved in some way with this situation. We shall see !
Like I opinionated earlier that Garnick should make a call or two. I'm sure he's connected to some individual that could pass along the message of Bavi......u think ??
Sad but true. Looks like death translates to money so why not let the dice keep rolling. Pretty lengthy article but it gives a good summary of where Ebola stands right now. I can't see why Bavi wouldn't be given a chance at bat....might really save our children....
Questions and Answers on Experimental Treatments and Vaccines for Ebola
For further information on drug development, approval process, and research please contact the appropriate agency:
What is ZMapp?
ZMapp, being developed by Mapp Biopharmaceutical Inc., is an experimental treatment, for use with individuals infected with Ebola virus. It has not yet been tested in humans for safety or effectiveness. The product is a combination of three different monoclonal antibodies that bind to the protein of the Ebola virus.
How effective is the experimental treatment?
It is too early to know whether ZMapp is effective, since it is still in an experimental stage and has not yet been tested in humans for safety or effectiveness. Some patients infected with Ebola virus do get better spontaneously or with supportive care. However, the best way to know if treatment with the product is efficacious is to conduct a randomized controlled clinical trial in people to compare outcomes of patients who receive the treatment to untreated patients. No such studies have been conducted. It's important to note that the standard treatment for Ebola remains supportive therapy.
This includes the following measures:
balancing the patients' fluids and electrolytes;
maintaining their oxygen status and blood pressure; and
treating them for any complicating infections.
In addition, the most effective way to stop the current Ebola outbreak in West Africa is meticulous work in finding Ebola cases, isolating and caring for those patients, and tracing contacts to stop the chains of transmission. It means educating people about safe burial practices and having health care workers strictly follow infection control in hospitals. This is how all previous Ebola outbreaks have been stopped.
Why aren't more people getting ZMapp?
At this time, very few courses of this experimental treatment have been manufactured. The manufacturer has indicated that the available doses have been distributed. Since the product is still in an experimental stage, it is too early to know whether ZMapp is effective. The manufacturer of this experimental treatment continues to research and evaluate the product’s safety and effectiveness. It has not yet been tested in humans for safety or effectiveness and much more study is needed.
Did the NIH play a role in getting the experimental therapy to the two U.S. patients in Liberia?
This experimental treatment was arranged privately by Samaritan's Purse, the private humanitarian organization, which employed one of the Americans who contracted the virus in Liberia. Samaritan's Purse contacted the Centers for Disease Control and Prevention (CDC), who referred them to the National Institutes of Health (NIH). NIH was able to provide the organization with the appropriate contacts at the private company developing this treatment. The NIH was not involved with procuring, transporting, approving, or administering the experimental treatments.
Will patients in West Africa be able to access this experimental treatment? How much supply is there?
The product is still in an experimental stage, and the manufacturer reports that there is a very limited supply, so it cannot be purchased and is not available for general use. The manufacturer has been planning for phase 1 clinical trials and does not have the capacity to manufacture large quantities of the treatment. The drug has not gone through clinical trials, meaning its safety and effectiveness has not yet been tested in humans. The manufacturer of the experimental treatment continues to research and evaluate the product's safety and effectiveness. The most effective way to stop the current Ebola outbreak in West Africa is meticulous work in finding Ebola cases, isolating and caring for those patients, and tracing contacts to stop the chains of transmission. It means educating people about safe burial practices and having health care workers strictly follow infection control in hospitals. This is how all previous Ebola outbreaks have been stopped.
Is ZMapp available under the Food and Drug Administration's expanded access to investigational drugs?
Currently there are only experimental treatments for Ebola virus infection in the earliest stages of development. When a drug is not approved, the FDA can authorize access to potentially promising products through other mechanisms, such as through an emergency Investigational New Drug (IND) application. In order for an experimental treatment to be administered in the U.S., such a request must be submitted to and authorized by the FDA. The FDA cannot comment on the specifics of ongoing drug development programs and cannot reveal information that is not otherwise public concerning submissions covering such programs such as IND applications submissions. The FDA stands ready to work with companies and investigators treating these patients.
Is ZMapp a vaccine?
No. ZMapp is being developed as a therapeutic product for treatment of people infected with Ebola virus, but not to prevent infection in the same manner as a vaccine. The best way to prevent infection currently is with stringent infection control measures.
What's the difference between therapy and vaccine?
Vaccines are usually given to people before they are exposed to a virus or bacteria that causes a disease. A vaccine stimulates the immune system to generate antibodies and cellular immunity that can fight off an infection if it were to occur. Typically, therapeutics are provided to people who are already infected with the virus. With the experimental ZMapp treatment, the monoclonal antibodies bind to the virus, so that the human immune system can clear the virus.
Are there Ebola vaccines available for use or in development?
There are currently no FDA approved vaccines for Ebola. The NIH’s National Institute of Allergy and Infectious Diseases is working on developing an Ebola vaccine. NIH recently announced they are expediting their work and are launching phase 1 clinical trials of an Ebola vaccine.
On August 28, 2014, NIH announced that initial human testing of an investigational vaccine to prevent Ebola virus disease will begin next week by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
The early-stage trial will begin initial human testing of a vaccine co-developed by NIAID and GlaxoSmithKline (GSK) and will evaluate the experimental vaccine’s safety and ability to generate an immune system response in healthy adults. Testing will take place at the NIH Clinical Center in Bethesda, Maryland.
The study is the first of several Phase 1 clinical trials that will examine the investigational NIAID/GSK Ebola vaccine and an experimental Ebola vaccine developed by the Public Health Agency of Canada and licensed to NewLink Genetics Corp. The others are to launch in the fall. These trials are conducted in healthy adults who are not infected with Ebola virus to determine if the vaccine is safe and induces an adequate immune response.
In parallel, NIH has partnered with a British-based international consortium that includes the Wellcome Trust and Britain’s Medical Research Council and Department for International Development to test the NIAID/GSK vaccine candidate among healthy volunteers in the United Kingdom and in the West African countries of Gambia (after approval from the relevant authorities) and Mali.
NIH is also supporting the Crucell biopharmaceutical company in its development of an Ebola/Marburg vaccine as well as Profectus Biosciences in its development of an Ebola vaccine. Additionally, NIH and the Thomas Jefferson University are collaborating to develop a candidate Ebola vaccine based on the established rabies vaccine.
Is the U.S. government involved in the development of ZMapp?
The U.S. government, specifically, the NIH's National Institute of Allergy and Infectious Diseases, the Department of Defense's Defense Threat Reduction Agency (DTRA), and the HHS' Biomedical Advanced Research and Development Authority (BARDA), has provided support for the development of this experimental treatment.
Are there other companies developing experimental treatments or vaccines?
Two other companies, Tekmira and Biocryst Pharmaceuticals, receive funding from the Department of Defense's Defense Threat Reduction Agency and have therapeutic candidates for Ebola in early development. The Department of Defense is working with a company called Newlink to develop an Ebola vaccine candidate. BioCryst, with NIH support, is working to develop an antiviral drug to treat Ebola virus that is expected to begin Phase 1 testing later this year.
UN: We Botched Response to the Ebola Outbreak
The Ebola outbreak already has killed 4,546 people in West Africa out of at least 9,191 cases. WHO says within two months, there could be new 10,000 cases of Ebola every week unless stronger measures to fight the outbreak are put into place.
Time to give Bavi a try ?
Tx rm
Thanks M.
Anyone know when the institutional ownership % will be updated ? Tia.
Thank you as well for sharing.
Ty for sharing.
From the 10/15 release...
"The recent outbreaks of Ebola infections highlight the need for novel clinical treatments and new combinations that are effective in treating the disease. We have a number of active collaborations exploring the potential of PS-targeting antibodies in infectious diseases and the results just published, along with a growing body of scientific literature, support potential applications of our PS-targeting platform in virus infections including Ebola," said Jeff T. Hutchins, Ph.D. vice president, preclinical research at Peregrine Pharmaceuticals. "Evolution has favored pathogenesis that exposes PS and these published results, along with other recently to be published data, have shown that PS is present during Ebola virus infection(1-3) and is important in the infection process. While our primary focus remains on advancing bavituximab in oncology, including our SUNRISE Phase III lung cancer trial, we believe these data warrant further collaborative investigation in Ebola and other infectious diseases including combinations with vaccines and active therapies that have shown promise."
It could join the crowd IMO.
D
Tx for sharing.
N
And that's exactly what is going to happen.
I'll go with Rob !
Robert L. Garnick, Ph.D.
Head of Regulatory Affairs
Dr. Garnick has over 30 years of experience in drug and biologic pharmaceutical development. He was formerly the Senior Vice President of Regulatory, Quality and Compliance at Genentech, Inc. Dr. Garnick spent 24 years at Genentech helping to found the biotechnology industry. While at Genentech Dr. Garnick was responsible for the approval of over 17 drugs, biologics and medical devices. He has extensive experience in analytical methodology, process validation, the regulatory review process both in the US and Europe and in Risk assessments. He has authored numerous scientific papers and has given numerous keynote presentations to the pharmaceutical Industry.
In due time.
Agenda driven.
Being close is all a matter of relative perception. IMO it means less time going forward than already spent. I also believe that BP will be front and center once the positive results begin to flow. I believe garnick hinted to picking up the pace once this occurs. I'll have to listen again ...
D
Very interesting thinking. I agree it's plausible.
I do like the fact that Garnick is confident at this stage and hasn't cancelled the trial progression.
That's the idea for bps to know if it works or not. If Garrick feels confident than I'm in it till the end.
D
Listen frustrated. Tia
Come on rob. Bring it on ! Plz
Getting sleepy
Safe harbor ?
Post 193143 of yours indicated to me that your not seeing the potential of Dr. T's Magic. Please share your technical analysis with me so I can understand what your purpose is. I see how pphm has survived jumping hurdle after hurdle in this race and the charts really mean very little IMO when it's applied to a bio tech stock of this character. Btw reading other posts of yours on other boards shows a pattern.
Good luck to u.
Norf'''mmm
Keep me posted Lenny on those charts. Tia
Lemmy. Any chart update please ? Tia.
Krak, did your friend give you that info ? Lol
Hope not. IMO we trend higher into the $2 range by months end.
D
That's the best that little pr**k can come up with huh ! Lmao
I thank him too. Lenny and I thank his dd as well.
I think of stocks like KERX...I know I rode that all the way down to $1.28 and then boom !
Actually many others did the same as you know ....IMO PPHM will do the same.
N
Nice Jim. All the best.
N
Make it a sticky.
Thanks CP. Now my eyes need to rest.
Norf'
I agree we need help from something.
For the longs that have been on this ride forever it's clear that the trials are not finalized and the pps is gonna be manipulated either direction. It's wait and see all over again and again. 9 months in already ...how time moves on. Tick tick.
N
It's looking for clues. I would find it constructive to guide if you care to share. If you need to criticize than pphm board isn't really what would do it for most. Relax cause at the end of the pphm road there will be the factual story. No more assuming. Wink !!!
Enjoy
Too many puzzle pieces to put together. The folks that will meet the bosses this year can push once again for some direction. Getting critical IMO. Lots of speculation and we need meat on the bone.
Sorry
Just venting a bit but optimistic.
N
Please share if you get somewhere with them. We are stuck ... Agreed.
So with all that said what are ones options. I see it as stay long or sell. It would be nice to see the sun rise but if one can not take the heat it's best to walk. This is bio tech and as most know the risk reward factor is justified. IMO we will conclude soon with some trial results on the horizon. The direction of pps is in ones mind for now and not in the technology ......yet.
N
I know your correct. I've witnessed too many that suffered ......
Go Bavi.
Dave
Wouldn't that be terrible. That would mean that Bavi failed and cancer patients would suffer. Hope your not hoping for that !