Aa
A
A
Close
Avatar universal
REP 9AC and Replicor
I have some feelings that Replicor might have ditch development of REP 9AC as so much has been said about it and nothing has happened in terms of making this magic cure HBV claimed drug available to patient. Is it to do with greedy as always by corporate organization? Surely someone should think of good name and history that comes with it. Lets write to Bill and Belinda gate foundation to speak to CEO of Replicor if this will help for guys in the USA.

Cancel
65 Answers
Page 4 of 4
Avatar universal
For Hep C they have a very good treatment plan worked out. We dont have  anywhere near the same success statistics with available hep b treatments.

But you do have a valid point that under current laws in the US a company can be fined very heavily if something happens to a patient. At the same time the government has not banned yet  the common practise of health insurance companies denying health coverage to hep b; c; and hiv patients. And usually those people out of desperation enter these clinical trials heaving  an already very poor health which in many cases prevents some people to be in the escalation dose group.

But I will still not side with drug companies like BMS.  
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
Then we need to try again to raise funds for them. And they openly have to announce it too.  We the sick people will all invest as much as we can .

Because if we start raising funds here and other forums in our countries without company announcing it. Nobody will go for. They will think it is another scam.

But if at Replicor on their website they put  a page with a mission statement. And paypal or alertpay donate buttons the action will start.

We can also email CNN or send a tweet to Anderson Cooper maybe they will air the information that a company with a historic HBV cure drug needs public support.  

Good idea was about contacting Bill Gates foundation. We can do that too.  So long as everybody just devotes a little bit of  their time by posting their support for this drive initiative  here and sends few in few words to Replicor CEO and invite her to answer some of  our questions here.

What is going with the company. And if indeed it is the funding issue then go to the people with your great idea to make this drug  happen.

I can sure well picture it how tough it is for a small company to swim with big sharks like BMS and Gilead. And I can almost bet on it that one of these companies is eyeing Replicor product.  
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
Sorry Stephen, the information dated this year only  says that "Replicor discloses information on the conference ...." but if you go to the conference site there is only the announcement, but no contents. If you are able to find anything newer than the info about the lucky 8 patient received REP9AC' in 2011 please be so kind to post it here. As for the price of 4000 per patient, it does not look too high if you compare the cost of life treatment with currently approved drugs.
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
You can raise fund to invest in any company including Replicor. Replicor invites investments, according to the laws and regulations of Canada, on its website. As far as I know, Replicor is not seeking investment from small shareholders, nor are they seeking donations from anyone.

Please remember, a company in Canada cannot solicit investment or donation without certain formalities, such as a prospectus or registration as association eligible to receive donations.

The most common response when you ask hbvers to invest - yes, sure, if it is a proven successful drug.
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
Look, people attending these conferences read the posters or heard the presentations from Replicor. They can ask questions too, face to face. There is nothing to prevent you from attending the  the coming AASLD conference and ask your own questions. As doctors and researchers paid to attend these conferences, the proceedings are usually not free to those who did not attend. As I said before, search previous posts here in MedHelp Hepatitis B forum for information about REP9AC.

As far as we know, there are only 8 in the REP9AC' clinical trial. We don't know whether they are more, you will have to ask the company.

Sure, 4,000 is not too expensive, I am sure some hbvers are willing to pay much more if it works. BTW, Replicor is not selling REP9AC, they are testing REP9AC at their own expense.
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
This is called lack of info, when you can not freely get it.
Anyway replicor confirmed to me that the drug will not come out earlier than in 3-4 years, so lets hope it will be so.
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
It is not lack of information, it is your lack of effort to find and willingness to pay.
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
I didn't it is illegal to raise funds online to cure 300 million people from HBV. But I am not too surprised these days  everything is illegal if it is done for the people and by the people.
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
The unofficial word is that Replicor is planning to sell their drug to a big pharma company. This is what they are  saying out there.

But I did find out something new today here - that it is even illegal turns out to raise funds online for cures. Big brother is controlling everything. Totally shocking.
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
Ok call it whatever you want but there is no free information available since 2011, if not please prove the opposite everyone will be happy here. All your references to your earlier posts are fruitless there is nothing new either.
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
guys lets not argue. Stephen showed us very good information. That right there for me is enough to say it works.

I mean look they cured of HIV now 4 people world wide with bone marrow transplant. They cannot find the virus in them even in the spinal fluid. And yet some people are still not convinced.

With Rep9ac we should look at how fast the surface antigen is coming down. From what is shown it is faster then everything we know of today.

Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
I repeat, do the search here to find the information. Don't expect information to be presented to you at your calling.
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal

the money for a full course of rep9ac was around 40.000-50.000usd a best, not less
the point is rep9ac is able to make hbsag neg and hbsab at best in 7 days and at worst in some months so if you cure so fast with a 40.000usd cost there is no pay back, especially with other drug makers selling life long antivirals at around 1000usd per month
in combo rep9ac+tdf or etv+peginterferon may clear even faster so it would be a total failure as profit for drug makers....this is why US drug makers are not interested

myrcludex trials may soon break this monopoly and with patent exp around 2015 hbv landshape may complitely change
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
It is illegal, in Canandian law, to raise fund from the public without a prospectus. This applies to most western countries too - it is called protection for the consumers. But the Canadian law says it is okay to raise fund from large investors without a prospectus because it is assumed the large investors know what they are doing - the risks involved.
Without these regulations, I can claim I have a cure for Hepatitis B and invited all of you to invest or donate without providing you with information in the form of a prospectus for which I am legally liable if it provides false or misleading information.

Secondly, you can raise money from donations. why don't you set up a website to claim that you are collecting donations to invest in a cure for Hepatitis B. The Hepatitis B Foundation is doing that exactly now for over 10 years. So it is misleading to say it is illegal to raise money from the public.
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
I understood your point -- you know that there is info somewhere but you will not tell where. It is ok you do not have to repeat this all the time.
I am not going to continue this argument any more, it is about nothing.
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
Why is this medication so costly?

On the other hand assuming people can come up with 50k for their treatment does it mean they would do it and make the medicine  available to those that can pay?
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
So there you have it. Why not would then HBV.org start this campaign to raise funds for Replicor.

And btw. If replicore folks  present this data to major insurance companies they would cover these resentments. A liver transplant costs 2 million usd and then 16k monthly to keep the patient alive. So 40-50k is not a lot really
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
so anymore ideas how can we talk with folks from Replicor about getting this drug?
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
Getting media attention Is the BEST way
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
news update-

http://www.replicor.com/debut_anglais2.htm
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
REPLICor discloses achievement of therapeutic vaccine-like responses in patients with chronic hepatitis B with short term exposure to immunotherapy in combination with REP 9AC’.



25 September 2012, Oxford, England.



Montreal, Quebec – Tuesday , September 25, 2012 – REPLICor is currently undertaking a proof of concept trial in patients with chronic hepatitis B (HBV) undergoing treatment with its nucleic acid polymer (NAP) REP 9AC’ in combination with Zadaxin™ or Pegasys™.  The hepatitis B surface antigen protein (HBsAg) is produced in large excess by the HBV infection as subviral particles (SVPs) which act to block the immune response to HBV infection.  NAPs act to block the release of SVPs from infected hepatocytes, providing an effective method for clearing HBsAg from the blood.  The elimination of HBsAg in the blood of HBV-infected patients is well known to be the best indicator of a curative response to treatment.



Interim results from REPLICor’s proof of concept trial were disclosed today at the 2012 held at the University of Oxford Christ Church and Examination Schools, Oxford, England.  Patients who had cleared HBsAg from their blood with REP 9AC’ monotherapy were subjected to combination treatment with REP 9AC’ and either Pegasys™ or Zadaxin™.  Profound increases in anti-HBV antibodies or immune function were observed in all patients with as few as 6-10 weeks of combination treatment.  Many patients have achieved HBV antibody levels seen in healthy patients after vaccination with a total of 12 weeks of combination treatment. All patients who have achieved this therapeutic vaccine-like response have been removed from treatment and continue to control their viral infections off treatment. The remainder of patients are expected to achieve full immunological control of their infection in the coming weeks.   REPLICor expects that the profound reactivation of a therapeutically effective immune response with short term Zadaxin™ or Pegasys™ treatment given in combination with its HBsAg release inhibitor REP 9AC’ can achieve durable immunological in most patients, regardless of viral genotype or state of their HBV infection.
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
tha's good !! can anyone tell when we will see that in the market??
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
At last something good and interesting to bring hope to millions of HBV chronic carriers..
Long live Replicor!
Long live brain behind the development and discovery!
Long live HBV chronic carrier!
Light in the end of tunnel
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
This seems like a real hope for all of us now. I just wish they can accelerate the process and get it to market quickly.
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
Appreciate it. But when I contacted them yesterday they are still saying that it takes 3 to 4 years to release into the market. Is it worth waiting? Won't other companies come up with similar curative drug till then? I think we should be concerned about this and raise our enthu levels to make the drug release at the earliest possible time, it's like now or never...
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
I agree with you.

This is what we need as a community to do - is to act, to make this company release the drug and save lives now. This is a humanitarian crisis, we are living it. And if there is a drug then just start giving it to people.

Some people are in real desperate situation. Especially guys with HDV..and People with drug resistant cytopathic HBV.

We need to organize here and e-mail them. And try to reason with them.  And have Michelle Bazinette come here and just read all of our life stories. Delaying the release of Cure for HBV cannot be about money or finding a better deal big buyer. If it is so then it is amoral given this is the 21st century.

But....  we can raise funds for them also. And those  of us that live in the western countries we can pay for our own treatment as well as for one other person that can't.

So say $10,000USD from a westerner is fair offer seems to me for a chance to start a new life as well as reward the company . I think in China and Russia patients can come with that too.. So that leaves just the third world that will get it free. And I have no problem with that paying for somebody I never met across the globe.

There has to be a way to release this drug. It is for the better of humanity.

And I think we need to talk with the Replicor CEO how can they make history. It does not really require much but a will to make a difference!

Health Care for profit and saving lives for money has to go - it is the worst forms of evil that unfortunately corporate medicine became today - it is just ugly.

At the same time they did the  research and should be rewarded financially  which we the patients can generate for them, maybe even governments if this idea takes off from the bottom up and the word spreads that some small company decided to make a historic change how it goes about releasing cures. Not waiting for some big pharma lending - private investor wall street fat cat globalist to decide who can have the drug and when to release it. Because if they have cures and they are not introducing them NOW that is eugenics. And we need to speak about it. And raise public awareness that cures for HEP B are being delayed to generate more revenue. In reality though these small drug companies would really profit more if they ditched their private investors and just open their funding to patients.

And this is what we HBV people need to understand that IF we don't stay together for this drug and make noise we will have to wait 3-5 years minimum. And a lot of people that can be saved will not make it. A lot of young people that can start a family and lead a productive life.

So this is what really we as international HBV community need to concentrate on. Make a real statement.

There is no other way..
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
I do not think that they can come up with the new drug faster than three years. What they have now is only the proof of concept that means that it theoretically works, but they do not know at the moment neither wright dosage nor side effects nor after treatment remissions etc. It takes to much time to test and define all that. If there are some sides that if most probable with a drug that actually integrates into your body they have to adjust the formula and do new trial etc. But I agree with you that if there is no such burocracy it could easily be 2-3 years instead 3-4.
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
They have the drug. Look at their results. This is their phase 2 I believe.  It is really the best available seems to me.

What they have showed here is enough to go ahead and start using on human volunteers. 500 people they can easily gather locally  and give them the drug again for 12 weeks. If 90% clear hbv then there you have it. Real solid results. From there all doors will be opened.

All it takes is a will of the head of company to be different.  
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
Probably it is too risky to test on 500 people at this stage...  
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
:) too risky is living with hbv. That is a risk right there.
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
I am still not conviced that Replicor is for real. Big pharmacuticals would be banging on thier doors if they had a drug that really does what they claim to do in thier Clinical Data.

Here are the things that make me skeptical about Replicor.

1. They haven't gone through the FDA process for the intent of producing a drug for theraputic purposes. Granted they are in Montreal, they can apply some where to legally go through the process of promoting thier drug.

2. Thier drug costs $50,000 to produce and it is done through infusion

3. They have clinical data, but no collaboration with University Sciences. See their clinical data vs the clinical data presented by companies like Gilead.

4. They have not released a single drug of any sort, they have no reputation behind them

5. They supposedly have a magical drug, that no other scientist or pharmacutical company has been able to even come close to.

6. They are very secretive and moving at a very slow pace.

To me thier drug sounds too good to be true, and comes with some of the things above that make me skeptical about it.  Anyone can purchase a booth at the AASLD and present anything they would like.
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
I totally disagree with your point about secrecy. Replicor has reported their results,albeit through posters, at all the major international Liver meetings. Please go to their website and read its news page.
You seek FDA's NDA if you intend to conduct clinical trials in America. Replicor never claims they have a magical cure. They report their results, they are confident that it is promising and are ploughing their own money and effort into developing it. They are not listed on the stock exchange so they don't hype. Is it their problems if big pharma don't invest in their product?
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
Its true that Replicor had not applied for NDA for clinical trial but i would totally disagree with his/er view.
I think they might wish to use their drug for rich people that can afford it and operate as a special drug and will never apply for anything to any regulatory authority.
Surely, what is known about Replicor and REP 9AC out performed any known HBV medication ever, so continue delay of this drug is increasingly suspicious.
I read about Dr. Michael Weitz a Californian emergency room physician and how he overcomed cancer and his decision to enter a Phase I study - the earliest stage of human testing for a new medicine - of crizotinib currently marketed by  Pfizer as Xalkori after an unusually swift development process. ( http://news.yahoo.com/insight-cancer-drugs-proving-worth-earlier-testing-064332072--finance.html) .
This is completely opposite to the response received by Dynavax from FDA on HEPLISAV (HEPLISAV is an investigational adult hepatitis B vaccine) See http://investors.dynavax.com/releasedetail.cfm?ReleaseID=742656
It appeared that all odds are against any development in HBV or rather these new developments are being delayed because the big guys are playing catch up.
Make your mind up.
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
Why do you think Replicor  delay the product?
It always takes 10 to 15 years to develop a new drug.
I do not think that there is lack of investors in the market at the moment, if big pharmas do not want  to invest, there are so many venture funds. If they needed money they would fond it. Maybe the drug is not as good as we hope?  
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
answer is simple if they cure hbv there is nothing to make money on for the future......so they dont invest and this is partcularly true for US drug makers

the only news is myrcludex investment by russian government thanks god, i dont like US to invade/impose their patented products to all world markets
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
I agree that it does take about 10 years to develop a drug but Replicor had been around for a while and conducted pre_clinical trial almost 7 years ago. They also added intf in an improved trial that proves to be success. What are they waiting for?
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
Telapavir and Bocepavir are both cures for HCV and are big money makers in the USA.
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal

hcv is different you can t have a drug to keep it under control and not cure, it can t integrate in dna and it mutates so mcuh more than hbv, they have no choice for it cure or no cure, no possibility of life long antivirals for it
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
They are waiting for people like you who believe they have a cure to put your money where your month is. Why is it that that others have to risk their money and effort while you just sit there and do nothing except to whinge?
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
Are they really big earner? Did you read about BMS spending 2.5 billion to acquire a drug that was supposed to be a cure for HCV, now they have to write off the whole amount as 9 people died in a further clinical trial? Gilead spent 11billion to buy a HCV drug , it is still not on the market.
If you believe in Rep9ac, put your hand in your pocket, if you don't, just carry on, it has not cost you anything.
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
I AM ok with putting up $50 000 and going through replicor treatment. All done confidentially of course. But we dont see anybody from their company come here and have a dialog with patients.

Stefano is spot on with everything he is saying. big pharma is not interested in cures. As it will take out hbv  nucs market. Thus hurt their sales.

Bottom line folks we need to work out  a plan with Replicor to try this medication. Those of that can pay can try it and then spread the word that it works. And you will.see.funds will start to come in so everyone would be able to try it.

That is why I say and urge everyone on this board. To stop focusing on nucs
Lets focus on Rep9 and how to get it. There must be a way to have a dialog with Replicor folks. After all they are a private company. We are a group of private individuals that want to make a deal with them.

$50k per patient to complete the treatment course. And it does not have to be in the Western country.
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
Come on guys, theres no need to start getting personal.

Any speculation is only from frustration of having the disease. having a very limited understanding on how drugs are brought to the market, and most importantly hope that your own speculation is wrong and there is in fact light at the end of the tunnel.
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
You have to also keep this in mind. That just because some large drug maker have spend a ridiculous amount.of money on something that did not work. Does.not.mean anything. All those numbers are inflated do to the amount of people involved in these companies.  Gilead and BMS are like government agencies by staff  and affiliates they have to support. so money is wasted  in these companies.

A small company spending a fraction what they spend can be just as efficient. so dont just just things or efforts on the amount of money they have spend on something.
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
The current.model of bringing drugs to market for diseases such as ours in NOT working.

As for frustration yes we are all frustrated. Replicor has the medication.that in combo with interferon or zadaxin cures. But we cannot try it or get it.  
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
No need to get personal-just read your posts. You make false accusation against a small company dedicated to finding a cure at their own expense and risk. This company is run by real people, you know.
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
"I AM ok with putting up $50 000 and going through replicor treatment. All done confidentially of course. But we dont see anybody from their company come here and have a dialog with patients".

Well if Repicor would come here publically and invite patients for non approved treatment protocols, then it would not be confidental anymore. The company would immediately be pursued legally and criminally and would likely have to shut down.

Furthermore, results obtained in such a way could not be used for the purpose of speeding up any legal application process.

The only way this would work is if they obtained approval in a small country , like Sciclone did it for Zadaxin and then patients would have to go there and unfortunately also have to pay out of their pocket. It is thinkable that Replicor might obtain early approval for this treatment in Bangladesch, since the local authorities have seen the impressive results and are therefore much more inclined to a speedy process.

Furthermore since the treatment is at least 6 month, as long as an  infusion weekly is needed, you would have to do that on your own. No doctor or clinic in the US would do it for you, not to mention the horrendous cost they would charge if they did.

Furthermore, how do you intend to monitor the results and your progress?
Since no quant surface antigen test is available here, you would not see the wonderful drop that you are likely to get after 6 to 8 weeks. Also your DNA curve needs to be monitored, as well as some safety labs that need to be followed.

You would need to introduce Zadaxin towards the end of the treatment at least, so you would need to get it from abroad, a difficult process. You could use PegIFN, but when to start it  is the question. Thus far no trial of a Replicor IFN combo from the start has been conducted, therefore it is unknown if this combo does not generate intolerable or truly dangerous side effects.

Your surface antibody has to be monitored as well, to give you an indication of when to stop treatment. It has to be quite high to give you a chance of durable SVR. And even that likelihood has not yet been established. In Amsterdam we will probably learn more about the current stability of SVR after immunenhanced Rep9ac'. But the time has not been long enough to make these SVRs a stable certainty.

Last not least , since you are e antigen negative, your chances to stably SVR are possibly substantially less than the currently investigated population of young e antigen positive patients, who have the reserve of core epitopes on their side for Tcell memory responses to hold the remnants in check. And you will have those remnants for sure , something has to permanently hold them back from regrowing. It has to be a combination of a strong antibody response together with the establishment of an effcient resident cd8 CTL Tcell memory population in your liver. There is no such thing as eliminating the last few HBV infected liver cells.

Thus how would you feel if after going through all these efforts you find yourself ,at a year after finishing treatment, with a rapidly rising surface antigen and viral load?

Also if you would continue the current antiviral during the treatment, you would not be able to see a DNA decline and as such you are pretty blind to monitor the true progress of your cccDNA elimination. Patients responded differently in the two previous trials and individual tailoring of stopping the infusions seems to be necessary to avoid a quick rebound.





Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
Thank you studyforhope, I read your response in this thread and the other one. Your knowledge of Replicor and optimism gives me reassurance that Replicor is in the works and could in the future help people.
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
I didn't accuse anyone of anything, at least I hope I didn't. I was just sharing a few points that made me feel skeptical. studyforhope clarified some of my doubts in another thread.

Looking back I could have probably chose my words more carefully. I've ready many of your posts and you've provided a great amount of support to many people, I just think that none of us should get personal.

I think its good to debate points with the intention to reach a better understanding of a topic.

Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
I was always curious about, since you are already explaining this, can you also please explain how this clinical trial in Bangladesh thing works? Lets say they successfully complete the trial and get all desired results & approval in Bangladesh in next 5 years, then how much more time does it takes to get approval in other countries?   Do they have to go through all clinical trials phases again? or after getting results from current phase, they would start clinical trials in other countries in parallel?
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Avatar universal
If the results are very convincing, it might help with the systematic approval process in the US and the EU. I am sure, that a phase II and III trial according to the standards in the US and EU are still required. Big companies like BMS conduct trials worldwide under FDA supervison and get the approval process started simultaneously in Europe and the US.
Small countries might have different rules, they might give approval by endorsement after reviews of the data and trial results. Sciclones Zadaxin is an example where US approval was never obtained, but many smaller countries were systematically added to the list of approved. In the US the required phase III trial never took place and the situation was overshadowed by the famous Mutchnick randomized trial in the US that had, instead of confirming the original promising data for HBV treatment with Thymosin alpha shown no significant effect in the larger multicenter trial.
Comment
Cancel
Comment
Avatar universal
Comment
Comment
Comment
Post Comment
Your Answer
Avatar universal
Answer
Do you know how to answer? Tap here to leave your answer...
Answer
Answer
Post Answer
A
A
Looking for a Doctor?
Shop for health care like an expert. Find the best doctors based on reviews from patients like you.
Hepatitis B Community Resources