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Regulatory milestones

Cadence Pharmaceuticals Inc. (NASDAQ:CADX) lost $1.16 (11%) to $9.34 last week after FDA issued a complete response letter for an NDA for Ofirmev IV acetaminophen to manage pain and reduce fever (see B9).

Cell Therapeutics Inc. (NASDAQ:CTIC; Milan:CTIC) fell $0.42 (40%) to $0.64 on Monday after FDA posted briefing documents indicating the company had not met the statistical hurdle in its trial of Pixuvri pixantrone. FDA also said the company's decision to stop the Phase III PIX301 trial early invalidated the company's SPA (see Online Links, A20).

The documents were posted ahead of an Oncologic Drugs Advisory Committee (ODAC) meeting scheduled for last Wednesday, which

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