Replies to post #6506 on Rich Pharmaceuticals Inc. (fka RCHA)

[sunspotter]

"ORHAN DRUG APPROVAL RATE is up .34.9% "

So what?

That's utterly irrelevant to the point I made which was to authoritively disprove your contention that 80-90% of designated orphan drugs get approved by FDA.

The real figure is 12.25%:

""2,979 drug-indications were listed in the FDA database representing 2,200 unique drugs. 365 of these drugs received marketing authorisation between 1983 and 2013. 266 drugs were withdrawn from the list. Nine drugs had an approval date earlier than designation date, and were therefore also excluded."

www.rare-diseases.eu/wp-content/uploads/2013/08/151_t5.pdf

In addition, while it may be true that such approvals are up by 34% (from a low number to a slightly higher number) the long term trend is down:

"Success rates for orphan drugs appear to be falling over time in both the US and EU."

ibid.