Posted On: 09/20/2014 11:38:25 AM
Post# of 30067
The most recent data from the FiercePharma website actually states that 5 out of 5000 molecules actually make it to market.
Now orphans I will leave to the copy and paste from the NPS board below:
showman01 • Sep 18, 2014 1:56 PM Flag
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FDA history with Orphan drugs and committee approvals (100% approval rate!)
Courtesy of Pastor Ken:
It is interesting to note that for Orphan products, the committee voting predictive power is 100%, meaning the FDA always followed committee recommendations. In fact, correlation between committee voting and FDA market approval decision is very high, reaching 90% for products given Priority status and 82% for a standard 10-month review.
Review Type Committee “Yes” Votes FDA Approval Decisions (and predictive power %)
Standard 45 (58.4%) 37 (82%)
Priority 59 (76.6%) 53 (90%)
Orphan 9 (60%) 9 (100%)
- See more at: http://lsconnect.thomsonreuters.com/fda-advis...tQoJJ.dpuf
Now orphans I will leave to the copy and paste from the NPS board below:
showman01 • Sep 18, 2014 1:56 PM Flag
11users liked this postsusers disliked this posts0Reply
FDA history with Orphan drugs and committee approvals (100% approval rate!)
Courtesy of Pastor Ken:
It is interesting to note that for Orphan products, the committee voting predictive power is 100%, meaning the FDA always followed committee recommendations. In fact, correlation between committee voting and FDA market approval decision is very high, reaching 90% for products given Priority status and 82% for a standard 10-month review.
Review Type Committee “Yes” Votes FDA Approval Decisions (and predictive power %)
Standard 45 (58.4%) 37 (82%)
Priority 59 (76.6%) 53 (90%)
Orphan 9 (60%) 9 (100%)
- See more at: http://lsconnect.thomsonreuters.com/fda-advis...tQoJJ.dpuf
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