MonoGen Withdraws HPV Supplement
CHICAGO, ILLINOIS -- Aug 10, 2007 -- MonoGen today announced that after further review and discussions with the FDA, MonoGen has decided to withdraw its HPV Supplement submitted to the FDA in June 2007. MonoGen currently intends to perform a new clinical study post market launch of its MonoPrep system with a different design to meet FDA requirements.
Ted S. Geiselman, MonoGen's President and CEO commented "After several discussions with the FDA, it has become clear that its approval requirements for the HPV Supplement will likely not be met with the information provided in our current submission. We will work with the FDA in the new study design and protocol and will initiate the study as soon as is practical after market launch, as such a clinical trial cannot be performed prior to market launch of the MonoPrep system. Although we remain pleased with the performance of the MonoPrep system in the current study, we believe that taking this action will provide a faster route to approval by the FDA rather than continuing with the current submission."With operational headquarters in the United States (Greater Chicago area), MonoGen is a medical device company developing an integrated suite of fully automated devices (the SAVANT LABORATORY SYSTEM(TM)) for anatomic and molecular pathology laboratories. The SAVANT LABORATORY SYSTEM(TM) is being designed to automate processes performed by clinical laboratories to reduce their costs, increase throughput, and improve the quality and consistency of results.
The common shares of the Corporation are listed for trading on the Toronto Stock Exchange under the trading symbol "MOG".
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