Hemispherx BioPharma (HEB)

[JohnnyD3]

So post something to talk about. :)

Here is my take on where we are for both drugs.

Alferon - not much to do here. The company is currently fully staffed and validating batch runs for an FDA inspection early next year.

Ampligen - there is some here, IMO.

The NIH has now promised to commit resources to ME/CFS

http://news.sciencemag.org/health/2015/10/nih-refocuses-research-chronic-fatigue-syndrome

This is a big deal. It has taken 30 years. The political winds are finally shifting with regard to this disease. How does this jive with ampligen?

The experts letter, pinned to the top of this forum, lays it out. As Carter said in the webcast, Hemispherx is "the last man standing' with regard to effective treatmentsfor at least a portion of CFS patients. (Rituximab trials in Norway are a long way from approval in the USA)

The FDA has approved ampligen for export to the European Union, Turkey, Austria, New Zealand. Maybe someone can find another unapproved drug, that meets the requirements of both the sending and receiving countries.... that qualifies it for export, for expanded patient access??

http://hemispherx.com/content/investor/default.asp?goto=833
http://hemispherx.com/content/investor/default.asp?goto=834

IMO, the FDA would not allow expanded access for these other countries, if they did not also have a plan for expanded access for the USA. All hell would break loose.

Hemispherx recently backed off on their price hike. Delayed until the end of March - which gives someone a 6 month window to get something done. With a record of a 17 YEAR treatment IND, it is difficult to imagine there is not a presumption of efficacy by the FDA. Otherwise they would have killed the Amp511 trial.

http://hemispherx.com/content/investor/default.asp?goto=847

Hemispherx spent a million dollars the past 18 months looking for a sub-group and a bio-marker. A bio-marker they can tie to improvements with ampligen. They think they've found such a biomarker.

http://hemispherx.com/content/investor/default.asp?goto=846

Maybe this period is just the calm before the storm??? :)