Kevin Sharer can keep that celebratory press release in his desk drawer a little while longer. The FDA didn’t issue a decision on Amgen’s Nplate yesterday as the biotech had expected, casting yet another gloomy cloud over the ceo’s ability to yank his company out of an ongoing crisis.

Amgen wants to market Nplate for a disorder that causes the body to attack its own platelets - the red blood cells that help blood to clot, resulting in bruising and bleeding after minor injuries. This affects about 200,000 people in the US, and Rodman & Renshaw analyst Michael King recently estimated peak annual sales of $500 million.

In March, an FDA advisory panel unanimously urged approval of Nplate. “We remain optimistic that a final decision will be made soon, but Amgen cannot speculate on the timing of the FDA’s response,” an Amgen spokeswoman tells Reuters. “Amgen continues to work with the FDA to assist in the completion of the review process.”

Just 10 days ago, BusinessWire issued a press release saying the FDA had, indeed, approved Nplate, albeit with certain risk management requirements. The premature release embarassed Amgen, which forced the news service to issue this retraction.