Cardima, Nasdaq make amends
This article was originally published in The Gray Sheet
Executive Summary
Firm's market value exceeds $35 mil. for 10 consecutive days, resulting in Dec. 28 notice from Nasdaq stating that Cardima has "regained compliance" with a rule that requires a listed firm to maintain stockholders' equity above a certain level. In June 2004, CDRH told Cardima it must conduct a new randomized clinical trial of its Revelation Tx ablation catheter to pursue approval for treating atrial fibrillation (1"The Gray Sheet" July 5, 2004, In Brief)...
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Cardima
CDRH officials tell Cardima at a June 18 meeting that a new randomized clinical trial of the Revelation Tx ablation catheter will be necessary to earn approval for an atrial fibrillation indication. The meeting was prompted by a May 28 non-approvable letter rejecting the firm's initial application for the second time (1"The Gray Sheet" June 7, 2003, p. 10)...
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