MTI regulatory, revenue projections
This article was originally published in The Gray Sheet
Executive Summary
Micro Therapeutics, Inc. expects FDA approval for an AVM indication of Onyx LES liquid embolic system in Q1 2004, preceded by clearance of Echelon-14 catheter this quarter, according to President and CEO Tom Wilder. In an Oct. 8 earnings call, Wilder projects 2003-2004 revenue at $28 mil. -$32 mil., and 2004-2005 sales at approximately double the current year's $22 mil.-$24 mil. He also noted that operating expenses - estimated at $37 mil.-$39 mil. this year - should decline to $28 mil.-$32 mil. in coming years, due partly to the absence of regulatory expenses incurred by the Onyx AVM PMA, which earned a favorable review from FDA's Neurological Devices Panel Aug. 5 (1"The Gray Sheet" Aug. 11, 2003, p. 10). Wilder predicts MTI will receive FDA sign-off by 2005 for a brain aneurysm indication, though he did not specify a regulatory path. The pivotal study is suffering from poor enrollment (2"The Gray Sheet" Aug. 11, 2003, p. 9)...
You may also be interested in...
MTI, FDA Revisit Onyx Aneurysm Trial Protocol: Enrollment Struggles Cited
Micro Therapeutics, Inc. is in discussions with FDA over revising its Onyx LES liquid embolic system brain aneurysm trial to better demonstrate efficacy in treating wide-necked aneurysms
Long-Term Onyx Implant Follow-Up, Labeling Conditions Stipulated By Panel
The FDA Neurological Devices Panel's cautious endorsement of Micro Therapeutics, Inc.'s Onyx LES liquid embolic system underscores the dearth of technologies available to treat brain arteriovenous malformations
Investors Go Berserk For Viking, Putting It Top Of Q1 Winners
The top 10 biggest share price winners and losers in Q1 from Evaluate show the investor frenzy for obesity drugs continues, while companies with governance doubts see shareholders retreat.