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Public Companies : Healthcare/BioTech


MonoGen Announces Facility Approval Delay

Apr 10, 2008 - 2:36:01 PM

News Source MARKET WIRE

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LINCOLNSHIRE, ILLINOIS -- (MARKET WIRE) -- 04/10/08 -- MonoGen, Inc. (TSX: MOG) today announced that it has received a letter from the FDA indicating that two of the six responses to observations received during the previously announced inspection of its facilities were not adequate and that a follow up inspection would be required. This letter stems from MonoGen's 180-day PMA Supplement filed with the FDA in October 2007.

"We are obviously very disappointed with this response from FDA", commented Ted S. Geiselman, MonoGen's President and CEO. "We believe we had adequately addressed the FDA's concerns; however we nonetheless look forward to their reinspection so that we can close out any remaining issues and begin distribution of the MonoPrep system. We are evaluating what the timeline associated with this delay may be and will do whatever we can to make it as expeditious as possible."

Forward-Looking Statements

This press release contains forward-looking statements. Statements preceded by the words believe, expect, anticipate, plan, intend, continue, estimate, may, will, and similar expressions are forward-looking statements. Forward-looking statements are based on our beliefs and assumptions based on information available at the time the assumptions were made. Forward-looking statements relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, new services, market forces, commitments and technological developments. By its nature, such forward-looking information is subject to various risks and uncertainties which could cause our actual results to differ materially from the anticipated results or other expectations expressed. Those risks and uncertainties include, but are not limited to, our ability to raise additional capital, our ability to execute our business plan while maintaining at all times our various regulatory approvals, and the competitive response from existing and potential competitors. Additional discussions of the various risks are contained in our Annual Information Form dated March 19, 2008, which may be found on SEDAR at www.sedar.com. Readers are cautioned not to place undue reliance on this forward-looking information, which is given as of the date it is expressed in this document.

Contacts:
MonoGen, Inc.
Investor Relations
847-758-4284
847-758-9392 (FAX)
investorrelations@monogen.com



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