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The stock is trading at $5.40 at about 9 am Eastern Time. This is down from last Thursday's close of $6.50.
Spectrum said that it has received a Complete Response letter from the U.S. Food and Drug Administration , or FDA, regarding its supplemental Biologics License Application,or sBLA, for Zevalin in the first-line consolidation setting for non-Hodgkin's Lymphoma, or NHL, patients.
Zevalin is currently FDA approved and marketed by Spectrum for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell NHL, including patients who have rituximab-refractory follicular NHL.
The FDA requested Spectrum to submit data files from the FIT study to support and verify a subset of the data that are currently under review to support the proposed labeling.
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