Hemispherx BioPharma (HEB)

[JohnnyD3]

Drug approval is not a personality contest. There is no "personal dis-like" of Carter from some higher ups - what gave you that idea?

It's not a perfect company, no company is, and when you develop a drug - at the FDA behest btw, whose mechanism of action is still being discovered, for a enigmatic disease with an ill defined cohort and in which, until recently, no government agencies believed existed. Well, you're going to have a bumpy road. the company has suffered a similar marginalization as CFS patients.

It's a very powerful letter. HEB is in a perfect position to benefit from either a NIH sponsored trial or conditional approval. By perfect position, I mean CFS is an unmet medical need, it has no treatments and, as the letter points out in so many words, ampligen is the only game in town and since it has been used for treatment since 19097 - they know it works for 25-40% of CFS patients.

Stay tuned - HEB has agreements for expanded named patient care in the EU, Turkey, Australia, New Zealand - the FDA will come up with kind of expanded access program - no way they will let the U.S. lag behind. HEB just had a PR that reinstates the old price until March of next year. That provides the time window for these programs, IMO.