ODS is designated for rare diseases. Being a 'rare' disease...

ODS is designated for rare diseases. Being a 'rare' disease concerned me a little until I researched what classifies as a rare disease, and that treatments usually cost more (provenge is $90K). Provenge is not a rare disease by definition. In the US there are 22,000 new cases of ovarian cancer. I would vouch >100,000 women have it and are alive. Possible close call for CVAC ODS (good thing).

Definition of the threshold of ODS follows:
(i) The disease or condition for which the drug is intended affects fewer than 200,000 people in the United States or, if the drug is a vaccine, diagnostic drug, or preventive drug, the persons to whom the drug will be administered in the United States are fewer than 200,000 per year
OR
(ii) For a drug intended for diseases or conditions affecting 200,000 or more people, or for a vaccine, diagnostic drug, or preventive drug to be administered to 200,000 or more persons per year in the United States, there is no reasonable expectation that costs of research and development of the drug for the indication can be recovered by sales of the drug in the United States

I doubt CVC would have got in on Point 2. I can't find the basis / reason for ODS grant...

Source:
http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/HowtoapplyforOrphanProductDesignation/DefinitionofDiseasePrevalence/ucm135130.htm

I've been working out possible income scenarios that I'll post in a separate thread.