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Posted On: 02/01/2018 11:15:55 PM
Post# of 72440
Actually the magic number is 73%.
“Special designations, such as Fast Track, Priority Review and Orphan Drug status, are awarded by the FDA to companies with particularly promising drugs under development. Innovation has received various FDA designations, reinforcing the potential of the company’s pipeline, while also providing better odds of a drug candidate's expedited approval, often with added exclusivity protections. Almost three-in-four drugs (73%) approved by the FDA in the U.S. in 2016 received some form of expedited development and review, with one-in-three (36%) representing first-in-class status. ”
http://www.ipharminc.com/special-fda-designations/
IPIX Drug Designations
1. B-OM - Fast Track
2. B-ABSSSI - QIDP (first-in-class)
3. K-OC - Orphan Drug
4. P - 505(b)(2)
We just need one of them to succeed and the odds are in our favor.
“Special designations, such as Fast Track, Priority Review and Orphan Drug status, are awarded by the FDA to companies with particularly promising drugs under development. Innovation has received various FDA designations, reinforcing the potential of the company’s pipeline, while also providing better odds of a drug candidate's expedited approval, often with added exclusivity protections. Almost three-in-four drugs (73%) approved by the FDA in the U.S. in 2016 received some form of expedited development and review, with one-in-three (36%) representing first-in-class status. ”
http://www.ipharminc.com/special-fda-designations/
IPIX Drug Designations
1. B-OM - Fast Track
2. B-ABSSSI - QIDP (first-in-class)
3. K-OC - Orphan Drug
4. P - 505(b)(2)
We just need one of them to succeed and the odds are in our favor.
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