In Brief: CellPro
This article was originally published in The Gray Sheet
CellPro: Firm hopes to launch its Ceprate SC stem cell concentration system during its current fiscal year (ended March 31). The device is in the final stages of FDA review following submission of additional information requested by FDA in an April 3 "approvable" letter, Larry Culver, CellPro's exec VP, chief operating officer and chief financial officer, says during an Aug. 12 session of the Medical Investments Northwest conference in Seattle. A good manufacturing practice inspection of CellPro's manufacturing facility was successfully completed in June. The device was recommended for approval by FDA's Biological Response Modifiers Advisory Committee in February ("The Gray Sheet" March 4, p. 11)...
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