Ampligen for Chronic Fatigue Syndrome: Another Deadline Come & Gone
First, a decision was due February 25. The FDA said it needed 3 more months to review data. The decision was then due on May 25, but on May 26 word came out that "staff scheduling changes" had delayed the final report. 1-2 more weeks, the FDA said.
The 2 weeks were up yesterday, and still we have no word on whether Ampligen will become the first drug ever approved for chronic fatigue syndrome. With widespread skepticism and cynicism about the FDA, don't you think the agency would at least try to get word out on time? Do these folks realize that millions of very sick people are waiting for access to better treatments? Wouldn't you think they'd at least -- in the interest of good PR -- put out some kind of statement if they're going to be late?
It would be one thing if this was a rare occurrance, but it wasn't long ago that they kept fibromyalgia patients waiting for a decision on Savella (milnacipran). A decision was due in October, but after that deadline passed the FDA said it needed more time, then made no further comment for 3 months.
It's not that I think Ampligen, or any other drug, is going to come along and work miracles for everyone with chronic fatigue syndrome. At best, it'll be an effective treatment for a few subgroups, and tolerable to a fair number of those. What gets me is that this agency utterly disregards its own deadlines and can't even be bothered to let people know what's going on. Knowing that this latest delay is all because a major government agency can't handle its own scheduling makes me all the more angry about it.
Of course, there's been a lot of buzz on Wall Street and the financial blogs about Ampligen, both positive or negative. Here's an interesting editorial I thought would address some of the points that have been raised here and elsewhere over the past week: Hemispherx's Ampligen: Fact vs. Fiction. It's a response to this article: Hemispherx Builds False Hope on Old Data.
I've sent a several emails to folks at the FDA asking when we should know, and I'm watching for an announcement. I'll let you know as soon as I know.
Comments
Thank you for your time and commentary!
The FDA announced the two week delay on a Tuesday. That would make today, June 9th, the correct deadline. I am anxiously awaiting a decision this afternoon.
Cameron,
I’m going by a standard business week, which is 5 working days. Yesterday was the 10th working day.
According to documentation from hemispherx, the deadline was most likely monday. The fda notified them the previous friday, not on tuesday.
On May 22, 2009, we were notified by the FDA that it may require up to one to two additional weeks to take action beyond the scheduled PDUFA action date of May 25, 2009.
Of course even if it was 10 working days, we should have heard something by today (6/9), which obviously is not going to happen.
get your facts up… the deadline wasn’t Monday. Its today and there’s still time left in today last i checked
rotflmfao…
what deadline???
clearly saying a week or two might imply 3….
duh….
Now that Carter has raised extra + $150 Million capital, the news (positive or negative) can come any time.
Vero, Carter hasnt raised an extra 150 million yet, he’s just filed the request to be able to do it with the SEC. They must approve it, then it needs to be brought to the shareholders meeting on 24th June where it will be voted on. Hopefully by that stage it will be approved and fewer shares will need to be sold to get the 150million requested.
I was in one of the original studies in San Diego. Ampligen was terrrible. It made me worse, and a lot worse. I know that there are a lot of people that are hoping that this will be the new miracle cure for them. But take it from someone who has taken this drug.. It is far from helpful. Hemisperx has been pushing for this to get approved from many years knowing that just about everyone with CFS will go out and get prescribed for it. It is all about $$$ and not your health. If you decide to take this drug, don’t blame me when you get worse!
I have had M.E. for 23 years. Quite naturally, I’m looking forward to help, rather than being told there is nothing for M.E.
Jason:- what problem did you have with this?
Check the above link with testimonials from real CFS patients on their experience with Ampligen. Jason – if you’re for real, I’m sorry the drug didn’t work for you but it obviously is helping other people.
http://www.cfids-me.org/aacfs/ampligen.html
I am getting more and more discouraged, as I’m sure we ALL are. Whether or not this drug will be the “miracle” we’ve been waiting for, the approval of the drug will bring with it MUCH needed public awareness and validation! I’m truly sorry that this drug didn’t work for some patients, but would still like to be able to try it. After 11 years, I’m willing to try anything at all to get my life back! The FDA has done nothing but put us off and it’s high time they at LEAST give us an update rather than just leaving everyone in limbo.