Posted On: 12/08/2015 3:50:18 PM
Post# of 72443
I'm really looking forward to the Prurisol data. If the result is impressive, then the 505(b)(2) pathway could be very beneficial because Phase 3 might not be required. If it's required, just one Phase 3 trial with few patients is needed.
"Once again, because a 505(b)(2) submission can rely in part on existing data, Phase III studies are often not necessary .
- If a Phase III study is required for a 505(b)(2), such as when approval is sought for a prodrug of a previously approved active ingredient, only one study is often necessary versus the two generally required for 505(b)(1) .
- Fewer patients may be needed for 505(b)(2) product clinical trials due to the existing large exposure information available in the public literature or in the FDA’s databases."
http://www.camargopharma.com/what-is-505b2.aspx
The middle child could very well be our first partnered drug.
"Once again, because a 505(b)(2) submission can rely in part on existing data, Phase III studies are often not necessary .
- If a Phase III study is required for a 505(b)(2), such as when approval is sought for a prodrug of a previously approved active ingredient, only one study is often necessary versus the two generally required for 505(b)(1) .
- Fewer patients may be needed for 505(b)(2) product clinical trials due to the existing large exposure information available in the public literature or in the FDA’s databases."
http://www.camargopharma.com/what-is-505b2.aspx
The middle child could very well be our first partnered drug.
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