Nearly 4 months after a decision was due, the FDA still has not ruled on whether Ampligen will become the first-ever approved treatment for chronic fatigue syndrome. Last month, the CEO of Hemispherx Biopharma Inc., the drug's manufacture, said that he expected approval this fall. He apparently later said it would be "by" fall -- but now fall is officially here, and there's still no word.
There was talk all summer about what the delay meant -- is there a problem with the New Drug Application? Is there some hidden meaning to all this? Or is the Ampligen decision just one of the many that have been put off while the FDA deals with a lot of changes?
Either way, with no word coming from the company and the FDA legally prevented from commenting on pending applications, it's disheartening to wait ... and wait ... and wait, while people who may benefit from the drug continue to suffer, and while the increased credibility and visibility that can come with the first drug approval remain on hold.
What has the delay done to your hopes of Ampligen being approved? Has it diminished them? Take the poll, and leave your comments below!
(Notice to finance folks: this is a health blog, not a financial one. Comments not dealing specifically with health or with the Ampligen approval timeline are inappropriate and will be deleted.)
Learn more or join the conversation!
NEWSLETTER | FORUM | BIO | TWITTER | FACEBOOK
While I don’t know what the final outcome may be, it certainly can get a little depressing. If I may share something a little off topic, but also in the spirit of struggling with hope (though based in a humble artistic impulse aiming to recover some), I took some time today to write Bad Blood: A Taste of Chronic Fatigue: a short vampire story. Hoping something light and abstract yet represented concretely could inspire more discussion of the issue. The post is released under a Creative Commons Attribution-Share Alike license, so by all means, feel free to share, improve or expand upon it as you like!
I’ve been holding shares in HEB for some time and despite the delays, the bashing by stock speculators like Adam Feuerstein, the stock price has held steady with considerable volume trading. A lot of people (including financial institutions in Europe)are holding their shares in Hemispherx BioPharma for a reason. A major expansion of the company’s manufacturing facility (4.5 million) was just announced in anticipation of increased production demands, and numerous trials of Ampligen’s unique immune system ‘boosting’ ability are currently in progress. All the indicators look very favourable for approval, and soon.
Well, my brain fog didn’t get me fired today but it may have started the wheels turning in that direction. I don’t know if I need Ampligen, but I need something.
24 years is too long to wait for a magic bullet. I’m just tired of it all. I don’t think I can keep up this facade much longer.
After almost 20 years of living a nightmare, like i am thinking through a tiny hole in my brain and the rest is black, like my body is being ravaged by infection (which I believe is HHV6A), with many of my relatives thinking I am just lazy, I have lost it all anyway – whether Ampligen gets approved or not. I hope it does for people who still have some hope left of salvaging something of their lives.
This long wait is MORE than discouraging. It feels downright criminal for those of us who responded so well to Ampligen a long time ago and need it again.
It’s like being tossed down into that black hole again after you have already seen the gorgeous daylight of LIFE……..a hard tumble. We are left to take medications which ARE approved and cause horrible side effects and may even kill us, but the one thing that works remains out of reach. At least I’ve had the experience of a life again, and shouldn’t complain. Others haven’t even had that chance. I’m angry, frustrated and VERY discouraged.
Waiting all these years, and once it IS approved, how long will it take to access??? More time, more time. Some of us may not have much more time, sadly.
I hate to keep saying it but Ampligen was invented in the early 1970′s and has been proposed for over 50 conditions.
HEB is a scam. Read the SEC filing dated 9/29…..HEB does not have the capability to manufacture Ampligen on a commercial scale. HEB dropped its drug liability insurance.
EVEN IF the drug is approved, which it won’t be, HEB cannot even manufacture it and is not insured.
What does that tell you after all these years.
Just to be clear…..I too want a magic bullet after 23 years. I am tired of being so freaking tired.