Ebb & Flow
FDA's accidental posting of briefing documents for Celgene's Revlimid a day ahead of schedule gave alert investors an afternoon of arbitrage last Monday. Typically, the agency posts its clinical and statistical reviews of a compound the day before it's discussed by an advisory committee, which means the documents should have been posted on Tuesday for Wednesday's ODAC meeting.
On Wednesday, the Oncologic Drugs Advisory Committee reviewed and voted to recommend approval of Revlimid lenalidomide to treat myelodysplastic syndrome (MDS) in patients with 5q chromosomal deletions. However, the briefing documents were inadvertently posted on Monday. An analyst told Ebb & Flow that he obtained the documents at 1 PM EST, but noted that they were available even before that. ...