TRIB next FDA approval monster
Unlike other biotechs, TRIB is PROFITABLE, it earned $.12 in its last quarter, its slowest quarter. 2 FDA approvals pending:
Trinity Biotech (NASDAQ:TRIB): On 3/10/09, TRIB provided the following update on the Company's new haemostasis (blood clotting) analyzer, Destiny Max, which has already been launched in markets outside the US. TRIB announced the submission of a 510(k) to the FDA on 12/23/08. TRIB expects to receive clearance and launch the Destiny Max high throughput coagulation analyzer in the US market toward the end of 2Q09.
On 3/9/09, TRIB announced the start of CLIA trials for its TRI-stat point-of-care HbA1c product, which is designed to measure HbA1c to assess a patient's average blood sugar control over the previous 2-3 months. Utilizing a patented boronate affinity and two-phase optical system, together with a simple, fully automated, plug-and-play instrument design, TRI-stat offers highly accurate results in minutes while eliminating the need for refrigeration required by three competing products. TRIB provided guidance that the trial would take about 4-6 weeks to complete at four locations at which point the data will be submitted to the FDA for CLIA approval.
