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SPPI - Spectrum Suffers BLA Setback But Based On Deadline It Was For The Better
Spectrum Pharmaceuticals Inc.
Spectrum Pharmaceuticals (SPPI) had to withdraw its Biologics License Application ((BLA)) of ROLONTIS after the FDA requested additional information. The information required doesn't call for any severe measures that will take years to fix; therefore, I believe that the biotech should be able to get the info completed in a timely manner. Once it gets the required information in order, it can quickly re-submit the BLA for approval of its drug again.
Setback On Main Drug
Spectrum had to pull out its BLA on its own because the FDA requested additional information. Specifically,