I am becoming concerned that CGNH is failing to meet its obligations to fully inform its shareholders and the investing public regards the status of its development of the POC analyzer. On February 3, 2011 CGNH announced a new timeline and final plans for testing of its QL CareTM (QLCA) Analyzer at 4 hospitals in North America against the Siemens ADVIA Centaur Analyzer and its related Troponin-I test.
CGNH had already identified the four hospitals that use the Siemens ADVIA Centaur and informed it would obtain approval from these hospitals. CGNH also informed that it expected to begin enrolling patients upon approval of the Institutional Review Boards, which it anticipated to receive by May 2011, and to complete the study in approximately 45 days. Final testing for the larger FDA study was expected to start during early Q3 2011 and be completed two months later.
Then in May 2011 at the 7th Annual Spring Growth Stock Conference in San Francisco Dr G presented an amended development schedule for the following Commercial Schedule for the POC Analyzer. The amended schedule called for "commencing pre-FDA" clinical study in Q3 2011 with results in 45 days. In Q4 2011 CGNH would complete the FDA study protocol and file the 510(K) for FDA clearance of the POC Analyzer.
As of today CGNH has neither confirmed the completion of the four hospital head to head study nor informed the initiation of the FDA protocol. This failure by CGNH is IMO unacceptable.