Analysts had expected approval for the drug and said it could reach annual sales of $800 million to $1 billion.
He said he expected final approval from the agency by next year to lift all restrictions on use of the plant.
If all goes well, he expects final approval by Dec. 17.
Administration officials expect approval to come in the next month.
Amgen had expected approval for the drug, which it calls Epogen, by the end of the month.
Industry experts said they expected approval to be granted.
He added that he expected approval by early next year.
Mr. Byer said the university did not expect approval of the 76 percent rate.
Charles Wang had expected approval in a few weeks.
People who throw unpleasant facts in your face fully expect approval as a reward for being open.