The company is not for sale. They have 40 million in cash and short term securities, very little debt and a burn rate of about 10 million a year. They have three other major programs besides CFS -- two involving ampligen, with all having the potential to be huge. The Breast Cancer study, which finished last month (we'll see data in a few months), is paid for by the National Cancer Institute. Over the last year and a half they have put 8 million upgrading their FDA approved manufacturing facility to produce Alferon-N (which is FDA approved) and Alferon LDO (a new formualtion that still needs approval) much more efficiently. They are not close to being a take over target.
You make some good points. It is a very challenging disease - non-homogeneous, no bio marker, a variety of co-morbidities, patients on a variety of drugs, broken immune systems. How do you design a trial? that is why other pharma's big or small have not tried, or have failed. We'll see who shows up this spring for the Stakeholders meetings that is supposed to attract drug makers. HEB has stated in conference calls that they have looked for a partner for CFS - the prospective partners tell them, let's see what the FDA says first, then we'll talk.
IMO, the FDA has not worked with Hemispherx, HEB applied 4 times for fast track approval, which would have kicked in lots of protocol and endpoint help from the FDA. The FDA turned them down every time based on CFS not being a serious disease. How goes the disease, so goes the company. IMO, the FDA is incompetent, corrupt and complicit. FDASIA was created to address some of these problems at the FDA. Large phase III trials are killing innovation. Average cost to get a new drug to market is 800 million. the FDA has authorized limited use of ampligen for 15 years - limited by a patients willingness to spend the bucks and relocate. Drug access for the privileged or for those willing to go absolutely broke. Shame on them.
Thanks for the vent.
Hi Jonny, could you do me a favour and shove a link in your reply to the HEB published accounts? Thanks. I figured I'd take a gander at what's what in the books. It's been a while since I did that sort of thing, but thought I'd enjoy seeing if I still can.
I won't address your 'concern' about the FDA but I will say that they
have recognised the seriousness of our disease. This was again apparent in their open letter reply posted I think above.
And let us not forget who the members of the review committee comprised. At least one of those voting 'no' on both major counts was a (as some might now say) 'previously' supportive member of the community I seem to recall.
These were not 'out to get us' or to snaffle our only hope. HEB are by your account 'cash rich'. Their executives following the review committee decision awarded themselves additional bonuses!
As patients we are biased. Naturally. There's rancour in the States against federal institutions, perhaps less so in the UK, though I don't know maybe not when push comes to shove and patients are wanting the latest drug regardless of expense as has happened with MS and Cancer recently for example.
With Ampligen I cannot see why they could not be
more selective in their cohorts. If HEB know this drug of theirs inside and out and back to front - after decades of study - then why the hell can't they tell who is most likely to benefit?
Surely 'immune profiles' would assist in this sub-categorising of patients from the CFS community? And quite how a drug for CFS could possibly also be marketed as being of use in AIDS let alone HIV is quite beyond my ability this evening to understand; but again, HEB must surely know.
What is it about those patients who have taken Ampligen in Clinical Trial that has allegedly seen them 'recover'? Why is it so hard to ascertain this fact? Can't they see a 'before' and 'after' profile and compare to the controls?
If Ampligen was 'good' for HIV/AIDS then surely they can explain why it is 'good' for CFS? Wouldn't that imply an aetiology? Leading to a biomarker of some description?
There is one aspect of the rehash of data I think it was that sticks in my mind and that is the
extra minute Ampligen permitted patients on the treadmill.
I might be incorrect in my recollection of this - but bloody hell - is it any wonder better evidence was asked for? Again. What were HEB thinking? Did they honestly expect - after all these years - for the FDA to roll over and stamp it approved based on nothing new?
I read Cort's article this morning, very briefly, and I see that he has also lambasted the FDA with nothing said about HEB in terms of criticism.
I need to read his blog-thing again tomorrow and reply. HEB made money out of the speculation before the committee decision. They did not release the concerns raised by the FDA into the public domain. They pocketed $8 million from this speculation so far as we know... some shareholders are prosecuting them.... and you've said they have $40 million sitting in cash....
But they don't have enough for a full clinical trial?!