PMR back to the drawing board
This article was originally published in The Gray Sheet
Executive Summary
CardioGenesis will not seek an FDA Medical Devices Dispute Resolution Panel review, following an unapprovable determination by the agency on the firm's PMA supplement for percutaneous myocardial revascularization (PMR). Further clinical work to gain approval will be considered during a future meeting with FDA, the company says. CardioGenesis cancelled an August 2003 dispute resolution panel review in an attempt to reconcile its clinical data directly with the agency (1"The Gray Sheet" June 2, 2003, p. 6). While CardioGenesis has not completely abandoned the notion of a future dispute panel review, the firm will focus on securing approval in Europe, Canada and Australia. CardioGenesis shares plummeted 29% on the news, closing at $0.74 on March 25...
You may also be interested in...
MCAC schedules TMR/PMR review
Medicare Coverage Advisory Committee will meet July 14 to discuss and make recommendations regarding transmyocardial revascularization and percutaneous myocardial revascularization for severe angina. Medicare currently covers TMR performed by PLC's CO2 Heart Laser and CardioGenesis' CardioGenesis 2000 for symptomatic relief of severe, medical refractory angina. CardioGenesis is developing a PMR system (1"The Gray Sheet" March 29, 2004, In Brief)...
FDA Dispute Resolution Panel To Review CardioGenesis PMR Data In August
CardioGenesis will rely on data previously reviewed by FDA in seeking to overturn an initial "not approvable" determination by the agency for its PMR percutaneous myocardial revascularization system
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”