oral ampligen, alferon LDO

[LaurelW]

It really would be nice wouldnt it - Im so curious to know how many people haven gotten well from it. So is it actually an xmrv inhibitor?

I was in the Ampligen 516 trial in 2003-2004. I pretty much got well on it, stayed well until last year. Turns out I'm XMRV+. Hemispherx is currently getting the banked 516 patients' blood tested by WPI. I'd be willing to bet that the other responders are positive too, and I'll bet they include that in the next study design that they have to do for FDA approval. It will probably make their efficacy numbers go up. (That's what my crystal ball says!)

 

[cfs since 1998]

I was in the Ampligen 516 trial in 2003-2004. I pretty much got well on it, stayed well until last year. Turns out I'm XMRV+.

It's good to hear you are an Ampligen responder that is XMRV+, so thank you for sharing that information. Sorry to hear you are sick again but at least we are a lot closer to answers this time.

Hemispherx is currently getting the banked 516 patients' blood tested by WPI. I'd be willing to bet that the other responders are positive too, and I'll bet they include that in the next study design that they have to do for FDA approval. It will probably make their efficacy numbers go up. (That's what my crystal ball says!)

Depending on how that goes they might be able to simply redo the statistical analysis from their Phase III trial and resubmit their drug application to the FDA, rather than go through another lengthy and costly Phase III. I don't know if the company is considering this or not but I hope this is an avenue they will explore.

 

[LaurelW]

Really? I thought one of the conditions the FDA set was that they had to do new trials on patients using a variety of doses. Don't know where to look this up. But whatever happens, the faster, the better.
:Sign Please:

 

[dannybex]

Really? I thought one of the conditions the FDA set was that they had to do new trials on patients using a variety of doses. Don't know where to look this up. But whatever happens, the faster, the better.
:Sign Please:

Yes, that's correct -- they need to do a new trial, with a larger number of patients, using different doses, for a longer period of time.

More info here:

http://www.biospace.com/news_story.aspx?NewsEntityId=164363

I'm glad you improved while on Ampligen, so I really hate to be a Danny-downer here, but I don't think it will ever be approved (in the US at least).

They've been trying to get approval for almost 30 years, plus the company's CEO has been accused on many occasions of lying to investors in order to boost the stock price. Apparently this happened again last year...where he suggested the FDA was about to approve it "within 2 weeks" (last June), which sent the stock soaring to $4.50 or so. As the summer passed, and there was no approval -- or any word -- from the FDA, the stock price slowly sank -- and then dropped 44% on December 3rd, when the FDA rejected it. It's now at around 48 cents I think...

On a positive note, it does say at this link that it's available in other countries: http://www.mahalo.com/ampligen

 

[cfs since 1998]

Really? I thought one of the conditions the FDA set was that they had to do new trials on patients using a variety of doses.

Yes, that's correct -- they need to do a new trial, with a larger number of patients, using different doses, for a longer period of time.

That is not quite correct. The FDA recommended they do a new trial, not required them. If they have new information, e.g. XMRV, that makes a persuasive case, they can reapply with a new analysis of the previous one.

They've been trying to get approval for almost 30 years, plus the company's CEO has been accused on many occasions of lying to investors in order to boost the stock price. Apparently this happened again last year...where he suggested the FDA was about to approve it "within 2 weeks" (last June), which sent the stock soaring to $4.50 or so.

What the CEO said about the FDA decision was true. The FDA delayed their decision for almost 6 months past their target date.