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WARRINGTON, Pa. - Discovery Laboratories Inc. said Thursday it plans to respond in September--much later than previously announced--to a Food and Drug Administration request for more information on its Surfaxin respiratory distress syndrome drug for premature infants.
| DSCO | 1.67 |  -0.07 |
On May 1, Discovery said the FDA requested more information on Surfaxin, delaying regulatory approval of the drug. The agency's request does not include additional trials.
At the time, Discovery said it would respond to the FDA in six to eight weeks.
The company added it believes the FDA will classify its response as a Class 1 resubmission, meaning the agency will take only 60 days to review it.
Shares of Discovery plummeted in morning trading, falling 42 cents, or 19.4 percent, to $1.74. Shares have traded between $1.29 and $3.58 in the past 52 weeks,
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