SPPI - Spectrum Shareholders In Limbo As FDA Delays Rolontis Decision Date Agrees To Discuss Poziotinib

• Spectrum is a $550m market cap biotech developing 2 drugs that are close to securing FDA approval but are subject to frustrating delays.
• A PDUFA date for Severe Neutropenia treatment Rolontis has been delayed until the FDA can complete a visit to Spectrum's partner Hanmi's South Korean manufacturing plant.
• A 7 Cohort trial of NSCLC treatment Poziotinib addressing EGFR and HER2 mutations has seen one endpoint missed, and another achieved.
• Spectrum shares traded >$10 prior to the Poziotinib trial miss but are now priced at $3.8.
• Approval of either lead candidate would likely trigger upside momentum, and there may be just enough evidence to support a bull case.

For further details see: