Replies to post #95876 on NanoViricides Inc. (NNVC)

[BonelessCat]

Exactly.

The FDA agrees:

"For a drug to qualify for orphan designation both the drug and the disease or condition must meet certain criteria specified in the ODA and FDA’s implementing regulations at 21 CFR Part 316. Orphan designation qualifies the sponsor of the drug for various development incentives of the ODA, including tax credits for qualified clinical testing."
http://www.fda.gov/forindustry/developingproductsforrarediseasesconditions/howtoapplyfororphanproductdesignation/default.htm

[GildedAge]

Thank you for putting this straight. And the best thing is, that you can view the granting of Orphan Drug Designation as an implicit appreciation of the drug by the FDA. I learned that 80 percent of drugs which received Orphan Drug Designation got later fully approved to the market.

[cfoofme]

Thank you for correcting the misinformation, as you always do, being the nanomedicine expert you are.


drkazmd65 Friday, 08/01/14 05:14:08 PM
Re: Rawnoc post# 95875
Post # of 95887
Not to to sink your battleship Rawnoc - but Orphan Drug refers to the treatment for a rare (or under-treated anyway) disease or condition and is aimed at what is called an 'Orphan Disease'.

So - the status is ascribed to the drug or treatment for that condition.

Your statement is incorrect.

For Example:
http://en.wikipedia.org/wiki/Orphan_drug

"An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease. In the US and EU it is easier to gain marketing approval for an orphan drug, and there may be other financial incentives, such as extended exclusivity periods, all intended to encourage the development of drugs which might otherwise lack a sufficient profit motive. The assignment of orphan status to a disease and to any drugs developed to treat it is a matter of public policy in many countries, and has resulted in medical breakthroughs that may not have otherwise been achieved due to the economics of drug research and development."

Or:
http://www.abk-ip.com/55.html

"Orphan Drugs are pharmaceuticals for the diagnosis, prevention or treatment of rare diseases."

So - when NNVC claims it has applied for (and recieved) approval for treating something of 'Orphan Status' - it refers to the treatment itself for that rare disease/condition as being the Orphan Drug'.