Something about the results of the part of the study in which Ampligen was compared to placebo made HEB decide to bury itl for the past two years and let it slowly fade away.
It is the IgA generated by Flumist that decreases the effectiveness of later doses of Flumist. An adjuvant that increases IgA would be very bad for this problem.
Here are the minutes of the ADCOM meeting:
"4) VOTE: Has the safety of Ampligen been adequately assessed and characterized for the
treatment of chronic fatigue syndrome (CFS)?
Vote: Yes= 4 No = 9 Abstain = 0 No Voting = 1
Committee Discussion: The majority of the committee did not agree that the safety of
Ampligen has been adequately assessed and characterized for the treatment of CFS, based
on the limited size of the database and the multiple discrepancies and gaps in the safety data
of the Ampligen clinical program. Some members stated that they had no confidence in the
veracity of the data and questioned whether the data were deceptive or just shoddy."
5) VOTE: Is the safety profile of Ampligen adequate for approval for the treatment of CFS?
Vote: Yes= 8 No = 5 Abstain = 0 No Voting = 1
Committee Discussion: While the committee members expressed that the safety profile of
Ampligen has not been adequately characterized for approval, many stated that if taken at
face value, the profile would be “good enough” for approval. "
So, they only voted that if you were to take HEB's data "at face value" that it might be "good enough." But they found that the quality of the data left them with " no confidence in the veracity of the data and questioned whether the data were deceptive or just shoddy." Hence they voted to recommend against approving Ampligen, and the FDA went on to reject Ampligen a second time
"The consensus from the Adcom was that there is a responder group for Ampligen. They wanted:
a) to define the affected subgroup with a diagnostic or biomarker
b) verify Ampligen's efficacy on the sub-group."
Is a total lie.
"there have been no tests or experiments that would justify a contract for Zika"
In this case, Equels is telling the truth.
But the boiler room prefers to engage in their own fantasies and lies.
HEB was able to raise millions of dollars with the bogus 2012 NDA, but they paid a heavy price when they trashed their reputation at the FDA and damaged what credibility they had left with the public by going through that cynical exercise.
Change in Directors or Principal Officers
Item 5.02. Departure of Directors or Certain Officers; Election of Directors;
Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On June 16, 2016, Iraj Kiani resigned as a member of the Board of Directors of Hemispherx Biopharma, Inc."
During the Kastis lawsuit, it came out that Kiani had:
1. Lied about his credentials and academic degrees,
2- That while supposedly on an independent litigation review committee, he admitted that he read none of the paperwork that Equels put in front of him and just signed whatever he was told to sign
3- That he was deceptive about the disastrous nature of his ersatz businesses and personal finances leading him to be dependent on the money he earned a director, hence making him "not an independent director."
While seeing one of Carter's incompetent cronies depart may, in some measure, be mildly good news, it really does not materially change HEB's dire financial condition or its dim prospects.
Why would anyone want to bribe the ADCOM panelists or the FDA?
The notion is ludicrous.
You just have to accept that when outside experts looked at the NDA that HEB submitted, they could easily see that it was totalcrap.
jonjonson/johnnyD spoke about FDASIA non-stop in 2012. But, he never really knew what FDASIA meant.
He was either bamboozled by HEB's press releases, or was paid to lie
"Where exactly are those analysts having predicted that 70-100 usd sales figure for 2016? "
I think that bonesnj0 had been guaranteeing $70-100 MILLION in sales. But, HEB will earn much less that $70 in commercial sales in 2016, in fact that number will very likely again be zero. They do raise some money by charging patients for participating in the cost-recovery AMP 511 study, but they usually only raise somewhere in the low six figures for this. And they raise zero dollars from selling any products on the market.
Here was their 2015 revenue summary in their most recent 10-K:
"Revenues from our Ampligen® Cost Recovery Program were $133,000 and $197,000 for the year ended December 31, 2015 and 2014, respectively. Although there was a slight increase in the patients utilizing Ampligen® in 2015, there was a decrease in revenue of $64,000 or 33% primarily due to a lower dosage being prescribed to patients utilizing Ampligen® during the current period. For the years ended December 31, 2015 and 2014, we had no Alferon N Injection® Finished Good product to commercially sell and all revenue was generated from the FDA approved open-label treatment protocol, (“AMP 511”), that allows patient access to Ampligen® for treatment in an open-label safety study."
2016 is likely to be very similar. Their insurance is reimbursing them for legal fees, but that money will go to their lawyers, (and by an amazing coincidence, HEB's lawyers work at Equels' law firm).
If the price keeps dipping, it just means that HEB will have to have a higher and higher ratio for the reverse split this summer.
Yes, and of course XMRV turned out to be a bogus artifact, not a real virus.
JohnnyD/jonjonson always seem to be pumping some new test for CFS.
Of course, all of their pumps are 100% bogus.
HEB is a spawn of Stratton Oakmont that has existed on bogus pump and dumps for its entire existence as a publicly traded company.
HEB's future is always easy to predict.
Just more vaporware.
HEB has been hyping deals with Argentina for many years, but has never sold any Alferon or Ampligen there, and never will.
Once a company trashes the presumption of its veracity in FDA submissions, it can be difficult or impossible to ever restore its reputation.
NK-Cell function is a very non-specific maker that really has no clinical value for either diagnosing or following the course of any disease or clinically relevant response to treatment.
Many things can make it go up or down, and whether it is up or down is a matter that does not translate into anything that is clinically meaningful.