OvaScience's stock plunged yesterday after the Cambridge company announced it had decided to temporarily suspend enrollment in U.S. trials of its in vitro fertilization drug while it resolves issues with federal regulators.
Shares dropped 23 percent to $10.95 after OvaScience revealed it had received a letter from the Food and Drug Administration asking the company to file an investigational new drug application for its lead product, Augment, which is designed to improve egg quality and increase the success rate of in vitro fertilization.
"This was not a final decision, nor did the FDA place our study on clinical hold," CEO Michelle Dipp said in a conference call with analysts yesterday. "We believe the FDA letter is largely based on preliminary information, and are very much looking forward to discussions with the FDA to provide details about Augment (and our) manufacturing procedures."
Those talks will help determine the company's clinical trials, timeline and budget, Dipp said.
An FDA spokeswoman referred all questions to OvaScience.
The company had aimed to complete its U.S. trials and begin selling Augment in this country by the end of next year, said Theresa McNeely, an OvaScience spokeswoman.
Its international strategy, Dipp said, remains "essentially unchanged." The company plans to proceed with an Augment trial outside the U.S. next year, she said, although she did not specify where.
"Our initial launch outside of the U.S. will target a few select countries, followed by continued expansion into other countries over time," Dipp said. "In preparation for the launch of Augment, we recently expanded our manufacturing capabilities by engaging a new global supplier."
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