Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Advanced Magnetics' GastroMark approval "imminent," CEO tells Oppenheimer conference.

Executive Summary

ADVANCED MAGNETICS GASTROMARK APPROVAL IS "IMMINENT," CEO Jerome Goldstein told an Oppenheimer & Co. health care conference in New York City Oct. 30. NDA 20-410 for the oral gastrointestinal magnetic resonance imaging agent became "approvable" at FDA May 7 ("The Pink Sheet" July 22, In Brief). FDA refused to file Advanced Magnetics' original GastroMark NDA in 1992 for lack of a disease-specific indication; the same NDA, without a disease-specific indication, was resubmitted in November 1993.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS029097

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel