The FDA is so late in issuing it's decision on Ampligen for chronic fatigue syndrome that we're about to start measuring it in months instead of days or weeks. Should this make us worry about the drug's chance of being approved?
No, it shouldn't. Here's why:
- The FDA hasn't asked Hemispherx Biopharma for more data.
- The FDA is behind schedule on pretty much everything right now (apparently because of the administration change).
- Most of the drugs that get to this stage of the process are approved.
So while the delay is incredibly annoying -- and potentially life-altering for some -- it's not a bad omen. Think of it as the last chapter in Ampligen's insanely long road to approval, and cross your fingers that the decision will come soon.
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Come on. Listen to the HEB conference call. It was a joke. Ampligen will never get approved for anything.
Carter used CFS as a means to line his pockets. CFS patients were fodder for the scam. Carter is now onto proposing his miracle drug as a vaccine additive to address swine flu.
Please.
“George” is a known paid basher.
it is disgusting how the bashing moves from financial mb’s to one about a debilitating illness. george has hit an all time low with this one!
The FDA is a bunch of pompus idiots playin political games with our lives.
It is sad that karma couldn’t make them all come down with cancer so they can fully understand what hope and the availibility of drugs mean-especially to a terminal patient,
I have had CFS for 23 years and I am very tired of reading articles that Hemispherx is on the cusp of getting Ampligen approved for treating CFS.
Listen to the conference call. Carter says that no new data is being requested, yet he admits that HEB is supplying data to the FDA when it is requested. Ask yourself..why would that be?
In June, the HEB PR department said that they had heard nothing from the FDA and now Carter says HEB is working with the FDA. What gives.
Maybe I am wrong in my assessment….but I fear I am not.
Of course I want a viable treatment for CFS, it is no fun spending most of my time at home. Then again, it angers me that Carter and HEB, in my opinion, are using CFS as a means to make money for themselves. If Carter cared about CFS patients, he would not have given himself a $300k bonus in May and instead would have supplied Ampligen to CFS patients for free, instead of on a cost recovery basis.
My opinion.
I don’t think anyone is under the impression that Dr. Carter “cares about people with chronic fatigue syndrome.” As the CEO of a pharmaceutical company, of course his goal is to make money off of disease — the same can be said of all drug companies, doctors, hospitals, health insurance companies, etc.
However, the financial motive gives them plenty of incentive to find drugs that actually work — that makes people a lot more likely to actually pay for them.
The fact is that most drugs never get to the point where Ampligen now is. While no one knows what the FDA’s decision will be, the decision delay doesn’t mean it’s more likely to be negative.
I think that over 18 years of false guidance regarding the imminent approval of Ampligen for CFS and the fact that Carter has proposed Ampligen to treat approximately 50 conditions is proof enough that HEB is a scam.
The old saying, fool me once…..
I owned HEB, then called HEM, in the 1990’s. I read Ossler’s Web the day it came out. I have listed to Carter’s conference calls for the past four years and all indications point in one direction…..Carter used CFS as a means to make money for himself.
Even if approved, which I think the drug will not be, it is very expensive, difficult to administer and would likely be a candidate to treat a small number of CFS patients, not semi-functioning patients like many of us.
It is time for Carter to take his Ampligen circus back home. It is too bad the CFS is a disease looking for serious acceptance and that Carter has hitched his wagon to our illness.
Listen to the conference calls. Carter does not even undersand CFS symptoms. According to him, we should all be dead from heart disease or suicide at this point.
I find it shameful. Again, my opinion.
I’m absolutely glad that Geoge’s “opinion” is one of very little credibility and with very little backing; as you can tell by the stock price.
Just because an individual chooses to make money of a drug does not necessarily mean they aren’t working hard to get it approved.
I’m an investor in HEB and am anxiously waiting the FDA’s decsion for Ampligen. Does that mean I do not really care for CFS patients? Not neccessarily.
George, whether you like it or not, your current diagnosis will remain with you, possibly forever.
My question to you,George, is why not be hopeful that one day the FDA will make the right decsion?
Its october almost november…STILL waiting LOL..
John,
See this link for newer information:
UPDATE: Ampligen for Chronic Fatigue Syndrome