URGENT: Email the FDA about Ampligen now and daily – final decision is imminent

January 6, 2013

by Sasha

The FDA will announce its final decision on Ampligen some time around 2 February but could make the decision much earlier.

The FDA will announce its final decision on Ampligen some time around 2 February but could make the decision much earlier.

“There comes a point in human suffering when acceptable risk is most appropriately determined for oneself, not by government.”

So said Suzy, in an online comment about the failure of the FDA Advisory Committee on Ampligen to vote in a manner that would have got approval for the drug’s use for patients with ME/CFS.

But it’s not too late. The FDA will announce its final decision on Ampligen some time around 2 February but could make the decision much earlier. So we have to act now to have a chance of getting Ampligen approved.

Cort Johnson and Bob Miller have put out a call for patients, families and friends to email the FDA, now and every day until we hear the final decision, to apply pressure to get Ampligen for patients.

There is still room for hope. The panel voted that Ampligen’s safety profile was adequate for approval. The vote on whether Ampligen’s safety and efficacy data supported approval went 8 to 5 against: two votes the other way would have made it 7 to 6 in favour.

We have to push, push now, push hard and keep pushing. Bob and team have produced a template email for us to use, reproduced below, which makes this an easy action. 750 of us emailed the FDA last time: let’s do it again. Please email, and do it now.

Would we like to have better data on Ampligen at this stage? Of course. But it’s an imperfect world and this is our chance. Having Ampligen approved would put the decision about risk and benefit in the hands of you, the patient. And it would validate ME/CFS as an immune disease – the knock-on benefits of that would be enormous, way beyond Ampligen itself.

To close with the rest of Suzy’s post:

“There comes a time when being alive does not equal living a life. Numerous cancer patients willingly suffer side effects of chemotherapy and radiation for a chance to live. CFIDS patients have been given a different kind of life sentence but are also fighting for their lives — give us a chance.”

Template email

 Click here to create your email automatically from the template, and copy in the suggested text below, or write your own message.

The addressees (already in the template) are:

HHS Secretary Katherine Sebelius, FDA Commissioner Margaret Hamburg, Director Janet Woodcock, Deputy Director Sandra Kweder, Senator Richard Blumenthal, Senator Kay Hagen, and Congressman Joseph Pitts.

To: Kathleen.Sebelius@hhs.gov, margaret.hamburg@fda.hhs.gov, janet.woodcock@fda.hhs.gov, Sandra.Kweder@fda.hhs.gov, Monica.volante@mail.house.gov

CC: Karen_Wade@hagan.senate.gov, Eamonn_Hart@blumenthal.senate.gov, 511bobmiller42@gmail.com

Subject: Approve Ampligen now

From: PLACE YOUR NAME HERE

The FDA should approve Ampligen by Feb 2, 2013. The advisory committee voted that Ampligen’s safety profile is adequate for approval. Patients and our physicians must have the opportunity to access a treatment that has shown such promise for ME/CFS patients. Failure to do so will leave us with no FDA approved options to treat this disease.

The FDA has stated that ME/CFS is a serious and life threatening disease. Yet, without treatment, patients and their families are left to suffer. Many of us are bedbound or homebound. We are in constant pain and suffering, abandoned to bodies that torture us every day and demands that we parse out our activities like a single piece of bread that must last for a month. According to a DePaul study, patients are more likely to die prematurely from cancer, heart failure or suicide. This is the long-term reality of living, untreated, with ME/CFS. Imagine living with an untreatable disease so terrible that you would choose suicide to escape it.

750 written and over 30 in-person patient testimonies, including that of the AAC patient representative, conveyed how this devastating disease impacts our lives and the imperative of weighing the opportunity to benefit against the risk of no treatment to escape from this terrible physical burden and get back even a piece of our lives.

For us, even small improvements have a very significant impact on our quality of life, which were dismissed by FDA statisticians. It’s evident that Ampligen has provided benefit to patients, with the testimony and data pointing to meaningful change in our ability to function and care for ourselves.

The true nature of this disease and the plight of patients have been ignored for too long. Patient testimony and patient and clinician experience provide evidence that this drug works in many patients. A number of AAC members agreed that Ampligen helps and other members noted that they saw an indication of effectiveness in some patients.

Let patients and their doctors decide whether the only treatment in FDA clinical trials for ME/CFS is the right medicine to provide relief from the living death that is our reality today. Remember that the disease itself has a collateral impact that creates its own serious risks for patients.

The advisory committee voted that Ampligen’s safety profile is adequate for approval.

Approve Ampligen by Feb 2, 2013. Anything less is condemning ME/CFS patients to years more of continued suffering without any hope of relief.

  

Support Phoenix Rising

 

56 comments

{ 56 comments… read them below or add one }

Sasha January 6, 2013 at 11:31 am

There's also an online petition that Bob Miller is supporting and that already has over 1,500 signatures (including mine, now!) – he's going to print it off and present it to the FDA.

http://www.ipetitions.com/petition/ampligen/

Please sign! Another quick and easy action that could make a huge difference in our lives.

Sasha January 6, 2013 at 12:35 pm

Freds, the petition's originator, on the petition thread just posted:

The petition has been getting a lot of response so far. I've been contacted by several advocacy groups and there's a handful of campaigns starting up to promote the petition.​
Robert Miller will personally be handing over the signature list to the appropriate parties in DC and is coordinating with Cort Johnson on how best to proceed.​
It looks like we're gaining traction, but the petition will need an all-out effort to reach the kind of numbers required for media exposure. The ultimate goal would be Congress — but we need your help!​
Some Twitter and Facebook activity can go a long way. Ask people to retweet your calls to sign the petition. Reply to sceptics that Ampligen was voted safe. Ask your Facebook friends what they would want. You *can* make a difference…​

http://forums.phoenixrising.me/inde…o-ampligen-online-petition.21099/#post-323408

justy January 6, 2013 at 2:11 pm

Thanks Sasha – done both, e mailed the template letter and signed the petition. Decisions in the US will affect patients all over the world. I want to be able to go to my GP or health board and tell them there is a drug being used to treat M.E/CFS and it is approved by the FDA.

All the best, Justy x

Nielk January 6, 2013 at 2:20 pm

Done. Done.

Sasha January 6, 2013 at 2:23 pm
justy

Thanks Sasha – done both, e mailed the template letter and signed the petition. Decisions in the US will affect patients all over the world. I want to be able to go to my GP or health board and tell them there is a drug being used to treat M.E/CFS and it is approved by the FDA.

Thanks, justy – and I agree that, wherever we live in the world, we all stand to benefit from Ampligen being approved. It would be a huge boost to our legitimacy. And, like you, I want to be able to go to an NHS immunologist and ask them what they're going to do to treat my immune disease when the FDA has approved an immunomodulatory drug for ME.

Sasha January 6, 2013 at 2:32 pm

That petition is rocking up to the 1,600 mark now…

Cort January 6, 2013 at 9:29 pm

It’s NOT a done deal. Ampligen didn’t win out but it did get a potentially critically yes vote.

While the panel did not vote that Hemispherx had sufficiently proved that Ampligen was effective or safe enough for full approval, they did vote (8-5) that Hemispherx had shown Ampligen was safe enough for ‘marketing’.

What does this mean? It means that most of the panel asserted that, given the needs of this population, Hemispherx had provided enough safety data for the community to be given a shot at the drug.

That’s a huge opening. That’s a prescription for conditional approval with restrictions by the FDA and that was made possible by the huge turnout by the ME/CFS population; a turnout the FDA called overwhelming, a turnout that broke their servers and a turnout that made them very aware of how much this community wants to have access to this drug.

Now, with the FDA in decision-making mode let’s make their decision as a difficult a one as can be. We are a force to be reckoned with. We deserve access to this drug. We know it works. We know every doctor that has used it for the past ten years strongly supports it.

Let’s bring Ampligen home for the ME/CFS Community. Please support this action.

Sasha January 7, 2013 at 1:59 am
Cort

made possible by the huge turnout by the ME/CFS population; a turnout the FDA called overwhelming, a turnout that broke their servers and a turnout that made them very aware of how much this community wants to have access to this drug.

I agree with everything you say there – and what was great about the last action was that we got to hear the numbers of patients and supporters who wrote to the FDA and it was huge.

Sometimes you write an email and have no clue if anyone else is doing it. This time we do know – people are pushing for Ampligen in HUGE numbers.

If you haven't already emailed the FDA, please do it now.

If you've already emailed, please do it again today.

If you haven't signed the petition, please do it now.

justy January 7, 2013 at 4:33 am

It took me less than 5 mintues and pretty much no effort.
Do it!

Merry January 7, 2013 at 6:37 am

Done. Simple.

Thanks, Cort, for the feedback on participation by ME/CFS community in the previous appeal to the FDA.

SickOfSickness January 7, 2013 at 10:38 am

Took me 1 minute!

Sasha January 7, 2013 at 11:04 am

Just done today's email – took a minute.

Also checked the petition, now over 1,700…

Forebearance January 7, 2013 at 4:53 pm

Done!
I probably wouldn't take Ampligen myself, but I understand how much this would help others, and with obtaining respect as ME/CFS patients.

Marg January 7, 2013 at 5:29 pm

Done..easy!

K2 for Hope January 7, 2013 at 6:31 pm

I had already signed the petition, but didn't know about the email, so thanks for putting this on the home page. I have now sent the email as well.

Even if Ampligen is not the "best" answer, it still will cause more publicity to the illness and we need that badly as most people still don't "get it".

I just spoke to someone today who said, "Oh, yeah, I heard about that illness." I had to explain about the Neuro Endocrine Immune disorder and the cognitive issues (not sure how well I did that….).

But, the more emails they get, the more they will realize there is a whole community of people who are watching and waiting for answers – all over the world.

So, as best as you can, if you can post something, here, please, please, try to sign the petition and send the email. It certainly cannot hurt…. and if it brings more recognition to this "severe and life-threatening" illness, then it has done something….

Thanks,
Karen

Nielk January 7, 2013 at 7:57 pm

Sent -mail again today.

Shell January 8, 2013 at 2:27 am

signed it. I am never convinced petitions make any difference. They ought to – but those who consider themselves in "power" are not going to be in "service" to those they ought to be. But no harm in trying.

Sasha January 8, 2013 at 2:54 am
Shell

signed it. I am never convinced petitions make any difference. They ought to – but those who consider themselves in "power" are not going to be in "service" to those they ought to be. But no harm in trying.

Thanks, Shell – normally I'd agree but this one is well-coordinated and backed by major players and will be printed off and presented to the appropriate person if it gets the numbers. It takes less than a minute to do so even if someone's a sceptic, better to do it than not!

Sasha January 8, 2013 at 2:57 am

Bob Miller has asked me to remove Sara_Mabry@casey.senate.gov from the list following guidance from Senator Casey's office and there may be other additions or removals according to response so please keep an eye on this thread. I don't have edit access to the article so changes might be slow to appear there.

Mouse girl January 8, 2013 at 4:36 am

I wrote a great letter to the FDA, I've been writing for all the campaigns that seam good to me. But, I have to say, I was completely deflated to see that only 750 people total wrote in. No wonder there is not much interest in this disease. Oh my, so sad.

Sasha January 8, 2013 at 5:20 am
Mouse girl

I wrote a great letter to the FDA, I've been writing for all the campaigns that seam good to me. But, I have to say, I was completely deflated to see that only 750 people total wrote in. No wonder there is not much interest in this disease. Oh my, so sad.

Hi Mouse girl – great that you've written and that you write in all these good campaigns.

The FDA saw the 750 people who wrote in as impressive, though. Relative to the response they normally get, it must have been big.

On research1st's account of the FDA meeting, it says, '[The FDA rep] emphasized FDA’s recognition of CFS as a serious disease with no approved therapies and acknowledged the strong public interest in the day’s topic as evidenced by written testimony submitted to the record by more than 700 people.'

http://www.research1st.com/2012/12/27/fda-panel-votes/

Live from the meeting, Cort tweeted: 'FDA states they were delighted and OVERWHELMED by patient response.'

http://forums.phoenixrising.me/inde…fate-in-live-webcast.20963/page-2#post-319208

That was certainly my impression – it wasn't just what that FDA rep said but how she said it – she seemed amazed (before my connection dropped out because we were present in such numbers that we stuffed up their servers).

Sasha January 8, 2013 at 5:22 am
Sasha

Bob Miller has asked me to remove Sara_Mabry@casey.senate.gov from the list following guidance from Senator Casey's office and there may be other additions or removals according to response so please keep an eye on this thread. I don't have edit access to the article so changes might be slow to appear there.

That's now updated in the text of the article so we can copy and paste or click or whatever! :)

Nielk January 8, 2013 at 7:01 am
Mouse girl

I wrote a great letter to the FDA, I've been writing for all the campaigns that seam good to me. But, I have to say, I was completely deflated to see that only 750 people total wrote in. No wonder there is not much interest in this disease. Oh my, so sad.

Interesting. To me, it seemed like a powerful response from a group of very ill patients.

Sasha January 8, 2013 at 11:50 am

Just done today's email.

Hope they're getting snowed under! :)

Mouse girl January 8, 2013 at 4:56 pm

Oh, thanks for sharing that info with me, Sasha. Makes me feel better. :)

Sasha January 9, 2013 at 12:55 pm

Just did today's email…

cph13 January 9, 2013 at 11:38 pm

completed, completed!

BEG January 10, 2013 at 8:01 am

Emails daily. Going to sign the petition now.

Sasha January 10, 2013 at 12:39 pm

Just done today's email…

The petition has over 2,000 signatures now.

BobM January 10, 2013 at 9:53 pm

Everyone, The 750 emails that gave your personal testimonies were amazing. The FDA was not prepared to get such a response. The numbers overwhelmed them to the point that they made specific comments several times, almost as a plea to say, We hope you're not angry with us. Patients did a great job by emailing and telling FDA what it's like to live with this illness every day and that we deserve a treatment. Anyone who was able to send an email should feel proud. And those who could not send an email need to know that those 750 emails helped to represent you and we as patients understand why you could not. We are currently sending in about 350 emails daily for the current "Approve Ampligen Now" action, if we could get that up to 500 emails daily that would be great. So again as a seperate action from the petition, ask friends and family to help any way they can and keep the emails flowing daily.

I am humbled by your support and your actions to help change our lack of treatments,
Thank you,

Bob Miller

Sasha January 11, 2013 at 1:55 am

That's really good to hear about the FDA's reaction, Bob – yes, let's get those emails boosted!

350 is great but 500 would be greater so if you haven't been emailing, please start now!

Sasha January 11, 2013 at 12:24 pm

Just sent today's email and checked the petition – over 2,100 signatures now.

If you haven't emailed or signed the petition, please do so now and keep emailing every day. This is a huge chance for us!

Sasha January 12, 2013 at 12:06 pm

Just done today's email.

Let's keep going – the decision will be made in the next week or two.

Sasha January 14, 2013 at 11:19 am

Just sent today's email.

The petition is at all the twos – 2,222 – maybe that's lucky!

If you haven't emailed yet, please do so now and keep doing it every day until we get a decision. Any day now!

Sasha January 16, 2013 at 11:20 am

Just done today's email.

There are 2,299 signatures on the petition – who wants to be the 2,300th? :)

Sasha January 17, 2013 at 1:14 pm

Just did today's email. Let's keep on trucking!

Freds, the sponsor of the online petition, wrote this on the main petition thread (if you haven't already signed the petition, please do so – it takes seconds and it's here – http://www.ipetitions.com/petition/ampligen/

We did well so far, but the sign-on rate has dropped in recent days.

I'd like to appeal to the community.

If you have an account on other boards or communities, it would be greatly appreciated if you could post about the petition there. If you're on Twitter or know someone with a large following, that kind of exposure is invaluable. The same goes, of course, for other Facebooks, printed press, etc. This includes audiences unrelated to ME/CFS.

An FDA "no" to Ampligen would significantly slow down investment in chronic diseases in general. They voted it safe. They're not contesting its effectiveness per se, they mainly insist on knowing which subset is affected more than others. We're not saying this doesn't belong in an efficacy profile, we're saying its added benefit doesn't outweigh the tremendous human and financial cost. It's an insufficient justification for keeping a potentially life-saving drug from bed-ridden patients with no alternative. Authorities in Canada and Brussels approved it 2 decades ago. Do you really think they're less diligent? Respect our right to decide with our doctors and provide incentive for sponsors to give drug companies the means to get those subsets refined.

We already know the subset that matters most. They're called ME/CFS patients.

Thanks for your support!​

Sasha January 18, 2013 at 11:28 am

Just did today's email…

Sasha January 21, 2013 at 3:05 pm

Just sent today's email – won't know what to do with myself when this is over…

dannybex January 21, 2013 at 6:40 pm

I don't get it. Why are people sending it duplicate (or daily?) emails? Surely each name will only be counted once. And what about those marked 'anonymous', with no message? Do you think they'll be taken seriously?

I don't get it.

???

Sasha January 22, 2013 at 3:52 am
dannybex

I don't get it. Why are people sending it duplicate (or daily?) emails? Surely each name will only be counted once. And what about those marked 'anonymous', with no message? Do you think they'll be taken seriously?

I don't get it.

???

Hi dannybex – the action we've been asked to do by Bob Miller, Cort and team is to send daily emails. I'm assuming the rationale is that a barrage of constant pressure will be more likely to change minds.

Imagine that you're one of these officials and that two weeks ago, you got several hundred emails on this topic and then they stopped. You haven't heard anything else from people for weeks and it's slipped down your agenda as other stuff has come across your desk.

Now imagine that every morning for the last two weeks your inbox has been flooded with hundreds of emails on this topic. You can't get away from it. You can see how desperate people are for Ampligen, they're emailing you every day.

Which scenario would make you more likely to take action?

I don't understand what you mean about 'those marked "anonymous" with no message'. The action is to send an email (which automatically has the sender's name, even if they forget to add it) and to copy and paste the message that Bob and team have prepared, if you don't want to create your own.

Sasha January 22, 2013 at 1:42 pm

Just done today's…

Have racked up quite the collection of autoreplies from Kathleen Sibelius :)

dannybex January 22, 2013 at 2:39 pm
Sasha

I don't understand what you mean about 'those marked "anonymous" with no message'. The action is to send an email (which automatically has the sender's name, even if they forget to add it) and to copy and paste the message that Bob and team have prepared, if you don't want to create your own.

Sorry, I should've clarified — I had seen the petition on the other thread (started by Freds?) — that's what I was referring to. There were several repeated names and quite a few anonymous "signatures".

The copy and paste technique for the emails does make it a lot easier for us to send messages — not sure how effective that is — but I guess we'll find out about 10 days or so?

Thanks Sasha.

d.

Sasha January 22, 2013 at 3:02 pm
dannybex

Sorry, I should've clarified — I had seen the petition on the other thread (started by Freds?) — that's what I was referring to. There were several repeated names and quite a few anonymous "signatures".

The copy and paste technique for the emails does make it a lot easier for us to send messages — not sure how effective that is — but I guess we'll find out about 10 days or so?

Thanks Sasha.

d.

Sorry, I should have guessed you were talking about the petition! If names are just repeated I'm assuming they won't be counted. As for the anonymous ones, those people will have given their name but ticked the box that allowed their name to be hidden on the website.

Yep, not long now to the decision so let's keep that email deluge up! With any of these actions, it's hard to know how effective we're being but the one guarantee is that doing nothing is the worst possible option. That email is a one-minute action – absolutely no reason not to email.

Sasha January 23, 2013 at 4:56 pm

Just done today's email, looking forward to Kathleen Sibelius's autoreply :)

Sasha January 24, 2013 at 12:42 pm

Just done today's email.

Maybe a week or so til the decision – could come any time, let's keep emailing…

Sasha January 25, 2013 at 2:03 pm

I've just done today's email using this excellent piece, issued by Dr Nancy Klimas, as the text of my message (discussion of her piece is on another thread):

Ampligen, the first drug ever seeking approval to treat chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), recently hit another roadblock with the U.S. Food and Drug Administration (FDA).

In its long quest to treat 1 million Americans suffering from this debilitating illness, the FDA advisory panel did not recommend the drug to be sold on the market, largely because CFS/ME doesn't have clear biomarkers such as blood tests to define patients who most likely to respond to the drug. Data from clinical trials of Ampligen has not convinced the FDA so far.

The real loser is not Ampligen, but CFS/ME patients whose daily suffering continues to be unabated. CFS/ME feels like you've been run over by a truck – pain, inflammation, utter exhaustion and trouble concentrating.

I have been caring for patients with CFS/ME for 26 years now. It's heartbreaking seeing them struggle and suffer from this serious illness that has been trivialized by science and society. One of the early controversies quickly disproven suggested that CFS/ME is a form of depression. This led to enduring public policies that allowed insurance companies to limit coverage to CFS/ME to either mental health or exercise therapy, neither get to the root cause of CFS/ME.

CFS/ME researchers, including myself, have seen major advances in our understanding of the biology of CFS/ME. It seems to resemble an illness we know how to treat like multiple sclerosis (MS), chronic viral diseases and autoimmune diseases.

Around since the late 1980s, this drug is not new to science and medicine. Two phase 3 clinical studies have been completed. The data shows that a subgroup of CFS/ME patients showed marked improvement, even recovery on the drug.

Yet, that's not enough evidence for the FDA advisory committee to approve because they would like to see a conclusive biomarker. As a physician, I could live with this decision if I had other effective therapies to treat my CFS/ME patients. But I do not. Moreover, it defies common logic in used in drug approval for other complex immune mediated diseases.

Take for example, MS: Its earliest approved treatments had opposite immune effects. One interferon increased immune activity and a second interferon quieted immune activity. In the studies that led to approval, MS drugs, like Ampligen, had about a 40 percent success rate.

Clinical research for these early MS drugs produced no biomarkers other than a patient's successful response to therapy, such as the case of Ampligen. The biomarker the FDA relied on for approval of MS — seeing if the lesions in a patient's brain decreased — had no correlation to the patient's improvement.

Why would the FDA approve MS drugs before there were concrete biomarkers to determine success? The answer is simple. The advisory panel saw MS as a serious disease that required interventions ASAP, and were willing to accept that clinicians would better understand where to use the first drugs with more experience using them. Now there are seven approved drugs for MS that have significantly improved quality of life for patients. But they are not willing to use the same logic for Ampligen.

Because CFS/ME patients are stilling waiting for their first therapeutic, Nova Southeastern University (NSU) in Fort Lauderdale, Fla. has brought on board a nationally renowned group of experts to form the NSU College of Osteopathic Medicine Institute for Neuro Immune Medicine, which will open in February.

These doctors and scientists will conduct basic research using genomics to help further develop drugs to treat this disease, while they treat patients. They are also doing clinical testing for Ampligen.

With or without a biomarker, the FDA should recognize the seriousness of CFS/ME and approve Ampligen, and open the door for other targeted therapies now.

Nancy Klimas, M.D., one of the world's leading researchers and clinicians in chronic fatigue syndrome/myalgic encepahalomyelitis (CFS/ME), is the director of the Nova Southeastern University's College of Osteopathic Medicine Institute for Neuro Immune Medicine.
Source: Nova Southeastern University

Sasha January 28, 2013 at 11:01 am

Just sent today's email.

The decision is expected around this weekend so let's keep the pressure on…

Sasha January 29, 2013 at 10:48 am

Just done today's…

Sasha January 30, 2013 at 5:09 am

Just done today's.

Decision any day now. Fingers crossed! Let's keep emailing.

Sasha February 1, 2013 at 4:46 am

Cort wrote a great email that he reproduced in the comments section of his blog that I'm using today for my own email (sorry about the formatting):

http://www.cortjohnson.org/blog/201…-on-hunger-strike-ampligen-approval/#comments

The FDA Advisory Board voted 8-5 that Ampligen was safe enough for conditional approval given the study data and 15 years of clinical data and the chronic fatigue syndrome communities needs. Disability rates are high in this condition and no drugs have been approved for it in its 20 years history and no other drugs for the disorder are under development.
Advisory Committee members were clear that the drug was safe enough even if more study data was needed. They offered a clear path for conditional approval that would provide Hemispherx, a small drug company, the ability to fund further studies. Without conditional approval Ampligen will probably disappear and chronic fatigue syndrome patients will lose their best chance at a drug that helps them.
The chronic fatigue syndrome community needs a chance at this drug. Approximately 4,000 patients have signed a petition stating so and over 750 provided written testimony to the FDA Advisory Board. So many patients watched the proceedings that they crashed the FDA’s servers.
Longtime chronic fatigue patient Bob Miller is currently on a hunger strike to emphasize the need for Ampligen approval for this disorder.
Please conditionally approve Ampligen for this community.

Research 1st February 1, 2013 at 8:17 am

What will happen if Ampligen isn't approved?

Sasha February 1, 2013 at 8:43 am

Hi Research 1st – as I wrote elsewhere:

If the FDA approves Ampligen for the US, then it's a game-changer for patients all over the world. There'll be an effective immune-system drug in use for our disease, which will validate our position that what we have is a genuine immune disorder. We'll be able to petition our governments for Ampligen and other immune drugs, as well as for a serious level of research funding. It will transform the way that the public sees us.

Research 1st February 1, 2013 at 10:35 am

Thanks Sasha. I must admit to thinking the same too and that we could get some respect from the medical community and that Ampligen would be a catalyst for being taken seriously.

I was really pondering though what will happen if the FDA reject Ampligen, and specifically what will Robert Miller do?
I hope he is prepared for a disappointing outcome. I remember watching his passionate speeches (CFSAC webcasts). He's a very determined individual and I hope he can cope with this if things don't go our way. Things haven't as of yet, ever gone our way.

Sasha February 1, 2013 at 10:52 am
Research 1st

I was really pondering though what will happen if the FDA reject Ampligen, and specifically what will Robert Miller do?

Sorry, I misunderstood you!

I don't actually know and, like you, I'd like to know. On the TV report about Bob's hunger strike (link below) Bob and another patient on Ampligen are interviewed and I got the impression that their Ampligen might be withdrawn but I don't understand why.

Here's the link, posted as a comment by Bob on Cort's blog:

Here is the correct link, to a news story about FDA and Ampligen HungerStrike Day 4, scroll down the page a bit until you see me in a thumbnail photo and click on that Block # 1, it is the first story is up, also has Dr. Janet Smith with me.http://www.mynews4.com/content/asseenonnews4/news4at6/default.aspx

caledonia February 1, 2013 at 12:03 pm

They keep adding new news segments to that page. You may have to scroll down the list to see the correct segment. Anyway, it's News 4 at 6 / 1-31-13 / Block 1.

Does this mean you won't be able to get it in the US, or does it mean they stop manufacturing Ampligen altogether without this approval? It is approved in Canada and one other country (can't remember which one). So presumably you could go to Canada to get it, and they have sales there.

dannybex February 1, 2013 at 12:18 pm
caledonia

Does this mean you won't be able to get it in the US, or does it mean they stop manufacturing Ampligen altogether without this approval? It is approved in Canada and one other country (can't remember which one). So presumably you could go to Canada to get it, and they have sales there.

I don't see why they would stop making it. It's been around for 30 years with no FDA approval…

???

p.s. I read on another board that that it's unlikely the FDA will announce their decision, but that the news would come from Hemispherx, but I have no idea if that's true or not.

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