An FDA Rejection Can Help Foster Confidence? The Compelling Case For AcelRx Pharmaceuticals
- A CRL typically has investors running for the exits, but in this unique case it has mitigated risk for biotech company AcelRx.
- The CRL was quite "soft", requesting no further human trails. Issues centered around instructions for dispensing device, infrequent dispensing errors, and shelf life.
- The company does not need to raise additional capital to fund operations through the next NDA and PDUFA. Issues are an easy fix and allow entry at a discounted price.