Phase 2 for Prurisol will be completed in 2016.
Post# of 72446
Posted On: 01/25/2016 3:55:21 PM
Re: NotRichYet2 #17920
Phase 2 for Prurisol will be completed in 2016.
Interesting word choice in the PR today.
"Commented Edward Walters, Head of Clinical Operations at Cellceutix. "The goal is to show the compound is safe and effective, while pointing us to an optimal dosing regimen for a late-stage trial.
"Cellceutix is developing Prurisol under FDA guidance that a 505(b)(2) designation is an appropriate development ..."
The following is a great 505b2 resource by the way.
http://www.camargopharma.com/what-is-505b2.aspx
". 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."
"In 2014, 50 percent of all NDAs approved have been 505(b)(2) drugs, with 41 new 505(b)(2) drugs approved compared to the same number of new molecular entities. This percentage is expected to rise to more than 80 percent over the next few years."
http://www.camargopharma.com/Userfiles/Docs/k...oducts.pdf
Interesting word choice in the PR today.
"Commented Edward Walters, Head of Clinical Operations at Cellceutix. "The goal is to show the compound is safe and effective, while pointing us to an optimal dosing regimen for a late-stage trial.
"Cellceutix is developing Prurisol under FDA guidance that a 505(b)(2) designation is an appropriate development ..."
The following is a great 505b2 resource by the way.
http://www.camargopharma.com/what-is-505b2.aspx
". 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."
"In 2014, 50 percent of all NDAs approved have been 505(b)(2) drugs, with 41 new 505(b)(2) drugs approved compared to the same number of new molecular entities. This percentage is expected to rise to more than 80 percent over the next few years."
http://www.camargopharma.com/Userfiles/Docs/k...oducts.pdf
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