How bad is this situation, are we finished or is there some way out of it. I guess there are more applications to the FDA scheduled with CK-MB, troponin I, myoglobin could be combined with these all together. In regard to the financing I heard that some of it had closed before the press release but still we are looking at more share dilution at perhaps at even lower prices, (gulp), So just what is the problem; did the FDA misunderstand the submission or did the paper get filled out wrong, I mean approval was expected. It appears that the clinical trials did not fully accommodate the point of care aspect of the application, so they have be done again?. What are these enhancements to the RAMP system they are talking about? Radvak still says that we are on track for marketing all three cardiac markers. I hope we can get some info from the company.
Best Regards to All
Dick
NEWS RELEASE
RESPONSE BIOMEDICAL TO RESUBMIT RAMP* MYOGLOBIN ASSAY
Vancouver, British Columbia, August 31, 2001. Response Biomedical Corp.
(RBM: CDNX), developer of the RAMP* diagnostic system, today announced its
intention to withdraw its recent 510(k) submission to the FDA. The Company
elected to withdraw the submission in order to perform further clinical
testing which will better address the intended point-of-care applications of
the technology and to include in the submission additional enhancements to
the RAMP System.
"We are absolutely confident in the performance of the RAMP System and its
ability, with the additional enhancements, to be a leader in the
point-of-care market," stated Bill Radvak, President and Chief Executive
Officer of Response Biomedical. "Development of the CK-MB, troponin I and
PSA tests is progressing on schedule and we are on track to market all three
cardiac markers in mid 2002, subject to our ability to continue to finance
the program. We are working closely with the FDA and plan to resubmit in a
timely manner."
About Response Biomedical Corp.
Response Biomedical develops quantitative, diagnostic tests for use with its
proprietary RAMP Reader for clinical, STAT-lab and point-of-care
applications. The RAMP System reduces the cost of healthcare by allowing
accurate, rapid and easy-to-use tests to be performed in hospitals, clinics,
laboratories and physicians' offices worldwide. The Company's platform
technology allows for the potential development of over 250 medical tests
that are currently performed by traditional laboratory methods. Response
Biomedical's shares are listed on the Canadian Venture Exchange under the
trading symbol "RBM". For further information, visit the Company's website
at responsebio.com.
The Canadian Venture Exchange has not reviewed and does not accept
responsibility for the adequacy of the content of the information contained
herein. The statements made in this press release may contain certain
forward-looking statements that involve a number of risks and uncertainties.
Actual events or results may differ from the Company's expectations.
Company Contacts:
John Gomez
Corporate Communications Manager
Response Biomedical Corp.
Tel (604) 681-4101
Fax (604) 412-9830
Email: jgomez@responsebio.com
Bill Radvak
President & CEO
Response Biomedical Corp.
Tel (604) 681-4101
Fax (604) 412-9830
Email: bradvak@responsebio.com |
