Eleven days after the company's new drug application (NDA) for AcuTect was reviewed by an FDA advisory committee, Diatide Inc. has received an "approvable" letter from the agency, which means the diagnostic test for finding acute venous thrombosis could be on the market shortly.

"We're looking at the third quarter," said Jill Sawdon, investor relations manager for Londonderry, N.H.-based Diatide.

The letter came exactly six months after the NDA was submitted to the FDA, which gave it a priority rating and convened the independent Medical Imaging Drugs Advisory Committee to consider it further. Diatide's application will be approved when the company clarifies certain details and formally agrees to specific post-approval requirements of the FDA.

"They told us they would review it in six months, and they did," Sawdon said.

Venous thrombosis is a clot that forms inside the blood vessels of extremities. AcuTect couples the radioisotope technetium to a small-peptide targeting agent to detect glycoprotein IIb/IIIa, which is only available when platelets become activated.

Current tests, such as ultrasound and contrast venography (which uses dye), are less specific. Ultrasound measures blood flow; if the flow is less, a clot is assumed.

Exact pricing for AcuTect has not been established, Sawdon said, but the company anticipates $300 per dose of the agent, which is injected.

Mary Ann Gray, an analyst with SBC Warburg Dillon Read Inc., of New York, rated Diatide's stock a "buy." She estimated U.S. sales of AcuTect will reach nearly $50 million in 2000, the second full year of sales.

Diatide is expected to file an NDA for its second product, P829 for the detection of lung cancer, in the second quarter of this year.

The company's shares (NASDAQ:DITI) closed Monday at $9.50, up $0.062. — Randall Osborne

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