Ampligen for Chronic Fatigue Syndrome: What's Behind the Delay?
The FDA's 1-2 week delay on the Ampligen decision has now stretched into nearly a month. While this kind of thing is hardly uncommon with the FDA, as time drags on with no announcement people are wondering if something more is going on. At least one Wall Street blogger thinks Ampligen's manufacturer, Hemispherx Biopharma Inc., will withdraw its application rather than have it turned down. That would save the company some embarrassment and allow it to focus its energy on studies of Ampligen for swine flu (H1N1). Then again, this particular blogger has been hammered for spreading misinformation about both the drug and the company, so it's hard to say whether his opinion carries any weight.
The delay, however, doesn't necessarily mean something is wrong. Last October, when the agency was supposed to make its decision on Savella (milnacipran) for fibromyalgia, it told the manufacturer it needed more time and then we heard nothing at all until January, when the drug was approved.
So what do I think is behind the delay? Hard to say, but it's certainly not a stretch to think that the FDA just hasn't gotten its you-know-what together enough to release a decision.
What do you think -- is this just bureaucratic foot dragging, or is some other agenda playing out behind the scenes? Do you think Ampligen will be approved? Do you think Hemispherx really will back out? Leave your comments below!
Comments
I am hoping that FDA will approve Ampligen not just because I am holding some shares but I believe that it is needed by patients. It has been proved to be safe or atleast not unsafe. Also it has some efficacy if not 100%. When there is no alternate medicine why not give Ampligen a chance especially when there are patients already confirming that it worked for them.
Thanks for sharing your thoughts on Ampligen. I think that there is a big difference between a drug being approved for Fibromyalgia and one for CFS. Fibromyalgia is in fact a real ailment that needs treatment. I don’t think that CFS is widely accepted as a real ailment yet and perhaps that is why a treatment is sitting on the shelf instead of being pushed through. I am no doctor, just another guy who got caught up in the “hype” a couple weeks ago when the stock took a wild ride. I hope that it gets approved if it really helps people but if they find that it has some serious side affects or issues then I hope that they will do the right thing and not put people’s health at risk
What if, with all this speculation, that it’s as simple as their last comment about under staffing? It’s just at the bottom of their TODO list. If so, maybe a flood of EMAIL would move it up. Would’nt that open up a new can of worms?
They have no intentions of pulling the application, as was clearly stated by Hemispherx’s head of investor relations in an email sent yesterday.
I believe the hold up is exactly like they said. The FDA under the new administration is undergoing major changes. I know here where I work when people get moved around, tasks and projects go untouched until things settle and people get into their role and figure out whats going on.
Other drugs have recently missed their “approval day” as well, so its not just Ampligen.
I am sure that under staffing could be a possibility. If this were the case why wouldn’t the company issue a statement addressing the continuing delay? I think a flood of emails from money hungry anxious investors would do absolutely nothing to speed up the process. I would hope that the FDA wouldn’t be moved by such an attempt but rather focus on the safety and affectiveness of the drug.
How about this…maybe it is as simple as the FDA now delaying their decision because now the company is tossing the drug into the vax arena too. Again, I am no doctor. From what I have read of the history of this drug it seems like it has been tested on a number of things. Finding a disease for the drug maybe? I am sure if they test it on everything out there then maybe it will eventually find its match.
I will continue to watch the headlines for the big announcement and if it is a yes then i am in with the rest of you.
I truely and honestly feel that timing is on Hemispherx’s side this time around except for the delay. I am sure that it will be approved when we all least expect it! Adam Funkystinky just harmed HEB’s price per share on June 5th 2009 by bashing on Ampligen, HEB and Dr. “Bill” Carter as he calls Dr. William Carter. My point is that when we all see against our very own eyes that Ampligen got approved we will also see Adam F. filing for unemployment! On behalf of all the people that suffer from CFS, please approve AMPLIGEN!! At the end of the day its not about us “investors”, it is about the people that suffer from CFS! May relief soon be with them. My respects and best wishes to all that hold HEB shares!
I thin HEB sent the last Data (Lovelace) very late, and instead of giving HEB a letter of complete response they will take the time to review it. It could take 90 days, so when one thinks that Carter submitted the first data in mid April, we have to wait at least another 30 days. best regards.
I can only imagine the time and effort it takes to come to a truly safe conclusion in regards to a drug that works on such a deep dna/rna level. Truly, in a lab scenario, this must take quite a bit of time. Especially taking into account that they do not have a hard substance to monitor; such as a vaccine where the effects could be seen on a slide. I truly do believe in this company and their efforts and have no doubt in my mind that this will offer an option to those that suffer.
My best wishes go out to those, and I truly hope that this will help open numerous doors for them in the future. If not, also open the eyes of the medical community.
The fact is no one knows the time line or if approval will come. It’s speculation and the increasing delay is working on investors nerves and leaving them more susceptible to ‘Journalists’ like Adam F. I used quotes because quite frankly Adam, and TheStreet.com for that matter has seriously damaged their credibility and objectivity. When someone continuously posts negative reviews and even lowers themselves to the point of personally attacking the CEO (name calling, slander) it becomes quite apparent that they have an agenda. This is not journalism nor is it listing facts and stating an opinion, this is a calculated effort with a particular goal in mind. In my opinion Adam F. is nothing more than a child standing in the middle of a playground yelling ‘Look at me’ in the hopes that someone might pay attention to him. His actions are both disturbing and painfully transparent.
Why should the FDA be allowed to hold companies and their investors hostage just because they can’t get their act together? I think at a minimum the FDA should be required BY LAW to provide a public reason as to why they delay approval decisions, how hard is that? I am not asking for the world, but I think in the fairness of transparency they need to be accountable for why they are so slow with our tax dollars at stake. No matter how sublime the reason!
Doctor Carter has used CFS as a means to line his pockets.
The man took a $300,000 bonus right after HEB shares popped on his proposed use of Ampligen for Swine Flu.
Carter should offer Ampligen to 15 CFS patients for a year free of charge, if he wanted to spend money. Instead, Carter does what he always does.
I feel it is shameful.
I am a reporter and cover the FDA. I’m also a person with fibromyalgia, which alwasy plagues me, and had my last severe bout of CFS in 2002.
I’ve been following this drug very carefully, and it is my opinion that it will be approved. The FDA right now is Swamped. It has not met most of its deadlines for drug approvals recently. That’s because the agency is still not fully staffed, there’s been a lot of staff transitioning into other agency jobs with the new administration coming in, and the new administration has all these new programs starting up: health reform, transparency, etc. Plus, with all the criticism FDA has received in the past few years, it is coming down firmly on the side of safety in its reviews.
On Ampligen’s side, it has good solid data, so much so that the agency did not request an advisory committee meeting. That is very rare. The advisory committees are made up of doctors in the specialty that would use the drug, and they review all the data and vote on whether the drug should be approved. FDA doesn’t always vote with them, but nearly all the time it does.
So, hang in there and be positive. I am!
‘Tom’, cfs is an accepted illness. However, in some countries, fibromyalgia and ME/CFS are treated as if they were not. This is why they are no real treatments for CFS.
Having had M.E for 25 years, am waiting and looking this up to see what happens.I’ve had enough of being tired, and want my life back -or to feel I’m having one in the first place, having had it so long now.
I have bought HEB stock in the hopes of there being good news about Ampligen.
As a Buddhist, I have just tried to think of CFS as not stopping me from living my life. I just see CFS as my life and live in spite of it.
And, I’ve written about it in a book that talks about spiritual recovery from all types of chronic illnesses.
I have been given a warehouse of lemons and now I plan to make oceans of lemonade and make it my career (in disguise).
Who knows where this will take me.
Kashakid
I have had cfs for over 18 years. I have been looking into ampligen for many years. what investors do not know is the people behind the scenes, not carter, but a person with great influence who family member got cfs, well she takes ampligen which got her 60% better. My point is if a very powerful well off family would put there someone they love on this to me it is safe and worth a try. they say those that will do the best on it are those that had EBV. There is so much more that people do not know. Maybe do some homework and look up the main doctor doing the clinical studies. There is going to be a new research facility, backed by a governer and senators, and leg. branch, it is being built as we speak to study CFS/ME. It is a nuro and immune illness. Ampligen so far is the only drug that gave some people there life back. NO not everyone will do well on it, mostly those that are bedridden with a virus, some may have HHV-6 or EBV, or CMV some may have all three. I meet people who tell me they have CFS/ME but they are working and functioning, this to me is not CFS. People with CFS/ME are bedridden. You will not meet them for they live inside there homes, they do not have a life. I use to be alive, working, making great money, I was so alive and fun, I lost everything after I got EBV. All my friends just gone, when I had money and a life, I had it all, once you get this ill, everyone disappears. It is very sad. I would love to tell you more. Look up WPI in nevada. NO way would they be building this place, it is going to be big news for CFS/ME. They already created a test that will prove people have this. There is a youtube on this it was in the news in nevada. Do some homework! There are now some big names that are going to inform people that CFS/ME a very serious illness. It is about time. I cannot walk anymore. I am becoming crippled. My life is a living hell, no treatments, no doctors, nothing. I am on a waiting list for a year, why? I hope ampligen gets approved so doctors take this disease serious and the gov. starts to do something about 4 million americans who have this. It is sickening how we are treated, animals get better treatment!!!! really. it is shameful that ampligen did not get on the market sooner, that is carters fault and I am not a fan of his,but ampligen and some others who want it approved I respect. if not for them, none of this would be happening. hope this was helpful.
Tom, CFS is only “not real” to people who don’t suffer from it. However, some skeptics do contract the disease and they are like rabbits caught in headlights…..completely stunned. I’ve suffered from CFS for 35 years, but wasn’t diagnosed until about 11 years ago, when I was trying to run my own business. I’m now a pensioner & sole father to 4 children. As you might imagine, I’m tired of being tired, not to mention stressed, depressed, forgetful, confused, disorientated, short of breath, arthritic……….etc. I’m also tired of being invalidated. This filthy stinking rotten disease is bloody REAL and I’d give anything for it to be not so. I wish there was a greater sense of urgency in the research.