update on finding of Ataluren FDA approval

Srobison

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<div class="headerNC">Top-line Data From Phase 3 Trial of Ataluren in Patients with Nonsense Mutation Cystic Fibrosis Show Promising Results

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Srobison

New member
<a href="http://www.pharmalive.com/news/index.cfm?articleid=843785">http://www.pharmalive.com/news/index.cfm?articleid=843785</a>
FDA approved it for fast track!!!!
 

Rebjane

Super Moderator
Where is that news release do you see anything about the FDA and it being fast tracked? I do not see that.
 

Rebjane

Super Moderator
http://www.drugs.com/clinical_trials/top-line-data-phase-3-trial-ataluren-patients-nonsense-mutation-cystic-fibrosis-show-promising-13812.html

Maybe it was at the end of this article?
 

musclemania70

New member
"The FDA and the European Commission have granted ataluren Orphan Drug status for the treatment of nonsense mutation cystic fibrosis and nonsense mutation Duchenne and Becker muscular dystrophy. The FDA has also granted ataluren Subpart E designation for expedited development, evaluation, and marketing for CF and dystrophinopathy and Fast Track designation for the development of treatment for nonsense mutation dystrophinopathy"
 
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