In From The Cold has this interesting story:
There's been a flurry of activity in recent months surrounding a new drug called CBLB502 and a company called Cleveland BioLabs. Less than two weeks ago, the Food and Drug Administration took the unusual step of labeling CBLB502 as an "orphan drug," reserved for medications used to treat rare diseases and conditions. The orphan drug designation came only four months after the FDA granted "fast track" status for CBLB502, accelerating its development and potential introduction.The short answer? Something in the strategic calculus has changed.
Why those designations for Cleveland BioLab's new product? Because CBLB502 is the only drug available to reduce the risk of death due to total body irradiation. The most likely cause of that condition: a radiological or nuclear disaster.
ince Congress passed the Orphan Drug Act 27 years ago, less that 250 new medications and treatments have reached the market, so that means CBLB502 is in very select company. It is the first designed to combat the effects of a massive radiation dose.
The rush to get the drug on the market raises a rather obvious question. The threat of a nuclear or radiological attack by terrorists has existed for more than a decade. If their capabilities in those areas have remained rather crude, why expedite production and introduction of CBLB502?