Discussion in 'Antivirals, Antibiotics and Immune Modulators' started by Wonkmonk, Aug 15, 2017.
seems like the usual attempt by big companies to boost share prices before their financial bonuses at awarded . it actually happens a lot
@alkt is correct. Typical Hemispherx PR that will make no difference with the FDA. Instead of doing the study the FDA requested FIVE YEARS AGO...
But those who wish to take Ampligen can now go to Argentina and get it there without trouble (if they have enough money) whereas it is difficult to come by in the United States and totally unavailable in the EU.
P.S. As for Ampligen's effectiveness, I am also rather sceptical. As @dannybex states, if it works, why don't they simply produce a reliable study?
Ampligen is approved for severe ME. How many severe patients can survive a trip to Argentina, I wonder?
Want to make clear, I am not in the business of defending Ampligen.
But one could reply:
(1) Reimport into the United States is, as I assume legal, or it could be bought by a relative and brought here.
(2) Probably the local doctor decides what is a "severe case," so it probably is also available to milder cases.
I doubt it will ever be approved. While there are a handful of patients who have done well on it (Mary Schweitzer is a noteable example), it's been around for decades, so that number should be higher.
And there's a good reason it wasn't approved the last time around. Their 2012 study showed after 40 weeks of the drug, it improved exercise tolerance by only 108 seconds. That's not even 2 minutes. For a very expensive drug.
You could probably do better with sublingual B12, for 1/10,000 of the price.
This is a year old? HEB actually got a "news" (it's an ad - read the disclaimer) segment and posted it on their Youtube. I legitimately wonder if a single Argentina doctor has ever or will ever prescribe this drug, assuming they've heard of it, and believe in CFS.
If you ask a doctor there to prescribe it (and pay him/her), I think it won't be a problem to get that prescription.
This doesn't seem to be new. If you go to the Hemispherx website all that's really being announced right now is this $5 million loss. (of course negative cashflow is to be expected for a biotech firm awaiting approvals and they're not without irons in the fire, including in Canada.)
Hemispherx Biopharma Announces Corporate Progress and Financial Results for the Six Months Ended June 30, 2017
The Company has Generated Revenues and Advanced in R&D for Intranasal Ampligen and in Immuno-Oncology
Conference Call Scheduled for Tuesday, August 15th at 1:00 PM EDT
PHILADELPHIA, Aug. 15, 2017 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE MKT:HEB): This quarter we see Ampligen® potentially repurposed beyond the single indication of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), to maximize the potential of this proven immunotherapeutic in indications in which a healthier and more stimulated immune system can play an important role in successful outcomes. We have made Ampligen® available in an Early Access Program for pancreatic cancer patients, looking at quality of life measures and collecting immunological data which we hope will help direct research into combinational therapies for this and other lethal solid tumors. We also see future opportunities for Ampligen® as a potential immune-enhancing vaccine adjuvant. As we recently announced, we believe that the intranasal human safety study of Ampligen® plus FluMist® known as AMP-600 indicates that intranasal Ampligen® is generally well-tolerated. Finally, this quarter we have made significant steps toward a potential New Drug Application in Canada for ME/CFS by working with patient advocacy groups and doctors, led by Millions Missing Canada.
Hemispherx announced its financial results for the six months ended June 30, 2017. The net loss was approximately $5,014,000 or ($0.19) per share as compared to a net loss of $3,467,000 or ($0.16) per share for the same six month period in 2016. Cash, cash equivalents and marketable securities were approximately $3,211,000 at June 30, 2017 as compared to $5,868,000 as of December 31, 2016.
Revenues from our Ampligen® Cost Recovery Program were $213,000 and $15,000 for the three months ended June 30, 2017 and 2016, respectively, primarily due to our Early Access Program, through our agreement with MyTomorrows, designed to enable access of Ampligen® to pancreatic cancer patients in the Netherlands. The increase in revenues of $198,000 is an increase of 1,320%. Revenues from our Ampligen® Cost Recovery Program were $297,000 and $54,000 for the six months ended June 30, 2017 and 2016, respectively. The increase in revenues of $243,000 is an increase of 450%.
We intend to continue our pursuit of profitable self-sufficiency while seeking FDA approval of Ampligen® in the United States and rapid expansion of our European operations.
I also notice on their site that Ampligen can be safely delivered nasally.
Hemispherx Human Safety Study of Intranasal Ampligen® with Influenza Vaccine Shows Ampligen was Generally Well-Tolerated PHILADELPHIA, Aug. 14, 2017 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE MKT:HEB) announced that it has commenced full data analysis of an intranasal human safety study of Ampligen® plus FluMist® known as AMP-600. The study was previously closed, but the initiation of full data analysis awaited the FDA’s evaluation of preliminary reports of blinded study findings. That evaluation was completed per formal notification from the FDA on August 9, 2017. Intranasal Ampligen was generally well-tolerated in the study.
108 seconds would be a big difference for some. And expense shouldn't be a factor in approving it. Merely safety and efficacy.
I agree that 108 seconds may be a big difference for some, but we'll probably have to agree to disagree that that equates to 'efficacy'. And at approximately $370 a second, that almost guarantees it won't be approved, even if we were talking about recognized conditions like multiple sclerosis, IMO.
(And that price estimate may be based on old information. Seems to me Hemispherx jacked up the price substantially a year or two ago?)
Edit: Of course that 108 seconds is the average, so no doubt some patients have had better gains.
And those patients who want to try it and can afford $370 per second can now go to Argentina...
stock down 10%.....nobody buying this news....
It's not news. This is a year old press release.
Earlier threads on Ampligen availability in Argentina:
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