SEC Filings
Cumberland Will File Duchenne Heart Drug Without A Phase 3 Trial, Though The FDA Raised Doubts
The drugmaker plans to seek traditional approval of ifetroban using its Phase 2 study, after the agency questioned the data package.
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SEC Filings
The drugmaker plans to seek traditional approval of ifetroban using its Phase 2 study, after the agency questioned the data package.
SEC Filings
The pilot study was not designed or powered to test whether the drug works, the company said, and most patients showed limited progression.