Discussion in 'General ME/CFS News' started by Bob, Aug 28, 2015.
So they seem to be anticipating success, and anticipating regulatory approval, and investing in facilities accordingly. If I've interpreted it correctly.
Even with success it could be years before they get approval. However one of the big sticking points has been that we do not know who are likely to respond, and who are not likely to respond. If they can find a marker for that then most of the arguments against approval of ampligen disappear.
Same thing with rtx. We don't know who will respond and who won't.
I'm an investor and attended the Open House. The facility is very impressive. Although some of the upgrade was for Ampligen, most of the facility upgrade went toward automating the manufacture of Alferon, Hemispherx's FDA approved natural interferon. I also advocate on behalf of a sister who has had ME/CFS/Lyme for over 26 years and was an ampligen responder.
The FDA has the ability to rule on some kind of approval at any time. There is a request to the FDA, from researchers, physicians, bio-medical experts, patients, for a 2 day meeting. A copy of the letter is on Cort's blog.
And Nancy McCrory, consultant to Heispherx for patient and physician education, addressed the FDA rep at CFSAC on this topic as well. Her public testimony is here, she is first up.
She also mentions that an expanded AMP511 Compassionate Care trial will be announced soon.
Hemispherx hopes to present the NK Cell function data that they have to the FDA. They have one exit meeting left on their NDA filing, that they've been putting off, after receiving the CRL, in order to gather more data to present.
An ampligen power point handed out at the open house, is available on their site here.
@JohnnyD - Are you aware that Hemispherx has almost tripled their price of Ampligen to patients in their "compassionate" open phase III trial? Did they discuss that at their meeting?
Yes, I'm aware of it and Nancy McCrory addresses it in her public comment. Watch the video... her comments are only a few minutes long.
I watched the video. What I don't understand is that Hemispherx needs these patients to complete this phase of Ampligen approval. They have just spent money to expand/improve their manufacturing plant. Yet, they have no problem billing these severely sick patients an exorbitant price, knowing that insurance will not cover it and that most of the patients will not be able to afford their life saving Ampligen going forward.
Nielk, technically, the amp511 has little to do with approval - it is a treatment protocol. The goal or "endpoint" is treatment. Period. I do agree, that it is hard to imagine that you'll be able to expand the amount of treatment by charging patients almost 3 times as much! So....
I think we'll have to wait and see what this new version of the amp511 looks like and see what it is they are offering patients to offset the cost. The company, a tiny biotech, has been supported by shareholders for the past 18 years or so. This is not a viable long term solution. Something must change. They need an income stream - which explains why most of the plant outlay went towards their approved drug, alferon.
As an advocate, I'd like to see them give a lot of ampligen away, to treat those who respond, to bolster their numbers for the FDA. However, with over 600 patients treated, 95,000 doses given, and the endorsement of the top doctors and researchers in the field - you wonder how much the numbers need bolstering.
As an investor, and this is a guess, I have no specialized knowledge of hemispherx - is that the recent agreements with the EU, Turkey, Australia, New Zealand, to treat ME - is that they need to establish the true cost of manufacturing the drug. What other company do you know that does a cost analysis of their products, once every 18 years?
No doubt that hemispherx has made mistakes in the past, they are not perfect by any means. On the other hand, they are the only company to try and develop a drug, with a degree of success, run phase II and phase III trials, specifically to treat ME. The only company to spend a million bucks, last year, to search for a biomarker that relates to the treatment success of ampligen. I think what many patients don't realize - hemispherx has no income, it has never had an income. The amp511 is cost recovery only. They've done well off the backs of shareholders, but it is no longer a viable path.
A bit more about the new facilities and the CFS research in another short article...
Hemispherx Biopharma Fully Aligns Executive Bonus Programs to Accelerate Product Revenue Opportunities and Market Entry
August 31, 2015
I hope this puts additional pressure on the FDA to accept the invitation to meet with the 17 ME experts and hemispherx and to come up with a conditional approval plan as outlined by the experts. If the FDA can reverse itself on obesity drugs and grant a conditional approval and approve a black label drug for female libido ---- surely they can come up with a plan for ampligen, to treat patients, who are very sick.
Of course that would mean that the NIH and the FDA would have to treat ME as a real disease. It's where the rubber meets the road.
PHILADELPHIA, Sept. 2, 2015 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE MKT:HEB) today announced it will be featured as a presenting company at the 17th Annual Rodman & Renshaw Global Investment Conference, sponsored by H.C. Wainwright & Co., LLC. The conference is being held September 8-10, 2015, at the St. Regis Hotel in New York City. Updates on the Company's Alferon(R) N manufacturing expansion program and the Ampligen(R) (an experimental therapeutic) Chronic Fatigue Syndrome (CFS) program will be provided including new data on novel biomarkers.
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