Data points from yesterday that brings confidence Itsa:
The European 2B trial will only be 12 months - great outcome....not protracted multi-year.
Trial efficacy end points accepted by agencies - Pul2 & Myoset (same as Aussie P2)
Agencies say positive results from Euro trial above paves way forward for EMA drug approval.
FDA discussion now back on agenda - maybe ANP will be white knight for Sarepta's FDA issues re Exondys51.
No CR until mid 2020 - awesome, means funding from elsewhere (Oppies,Partnerships?)
Sarepta net quarterly revenue US$95m from 13% of market AU$500m annually.
Sarepta need to satisfy FDA efficacy requests pronto!
New IP / clinical studies for new indications targeting CD49d.
My thoughts: if any BigPharma is looking on with interest, surely they will move before Phase 2b is complete, otherwise they will be paying premium $$$ by that point if 2B is successful.
Phase 2 is the "sweet spot" for Biotech M&A.
Pipe-dream maybe. But very probable given Sarepta's predicament.
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Data points from yesterday that brings confidence Itsa: The...
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