Replies to post #12948 on Hemispherx BioPharma (HEB)

[JohnnyD3]

You wonder why the FDA cannot work with HEB under FDASIA. If they need a surrogate endpoint, declare the primary endpoint a surrogate. That way, patients get some treatment now and the FDA gets a post marketing trial to satisfy the trial requirement. This kind situation (a drug that is promising, safe) is why FDASIA was created.