European Patent for Exon Skipping for DMD Granted to Japanese | SRPT Message Board Posts


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Msg  14368 of 14374  at  7/14/2021 1:44:21 PM  by

pineappleguava


 In response to msg 14367 by  schmiggins
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Re: European Patent for Exon Skipping for DMD Granted to Japanese

I gave up on waiting Sarepta for so many things.  I do, however still check twitter and your posts from time to time.
 
Remember their plan to meet with the EMA for eteplirsen?  This is from their 2020 10-K filed in March 2021.
 
"We are pursuing regulatory approval of eteplirsen in jurisdictions outside of the U.S. In November 2016, we submitted a marketing authorization application (“MAA”) for eteplirsen to the EMA and the application was validated in December 2016. As we announced on June 1, 2018, the Committee for Medicinal Products for Human Use (“CHMP”) within the EMA adopted a negative opinion for eteplirsen. In September 2018, the CHMP confirmed its negative opinion for eteplirsen, and the European Commission adopted the CHMP opinion in December 2018. During 2019, we sought follow-up EMA scientific advice for eteplirsen. Once data from our ongoing studies is available, we plan to evaluate future engagement with the EMA on potential next steps." 


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Msg # Subject Author Recs Date Posted
14369 Re: European Patent for Exon Skipping for DMD Granted to Japanese schmiggins 0 7/14/2021 3:31:50 PM


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