AHPC Holdings (Glendale Heights, Illinois) said it has received a Nasdaq Staff Deficiency letter indicating that the company is not in compliance with requirements for continued listing because its shareholders equity amount is below the minimum requirement of $2.5 million. AHPC said it is considering its options. If it is unable to deliver a plan to achieve and sustain compliance with all Nasdaq listing requirements that is acceptable to Nasdaq, the company expects to receive notification that its securities will be delisted.
AHPC Holdings markets disposable medical examination, foodservice and retail gloves.
Veridigm finalizes name change
Veridigm (Los Angeles) said it has finalized its name change from eNotes Systems and its new symbol VRDG is in effect. The company develops telemedicine products and services for hospitals, medical facilities and other healthcare-related centers throughout North America.
Differing thrombosis definitions provided at FDA’s panel on DES
What’s in a word?
Parsing the meaning of language is a challenge even for the politically inclined, but attaching meaning to the word “thrombosis” during the FDA meeting on stents proved more exciting than the average layperson could have anticipated.
The ARC (Academic Research Consortium) definitions encompass three levels of certainty. For definite/confirmed stent thrombosis, the definition is acute coronary syndrome and angiographic confirmation of stent thrombus or occlusion or, alternately, pathologic confirmation of acute stent thrombosis. The definition of probable thrombosis is unexplained death within 30 days or target vessel MI without angiographic confirmation of stent thrombosis or other identified culprit lesion. Finally, possible stent thrombosis is inferred by unexplained death after 30 days.
The definition of stent thrombosis (ST) to 30 days employed by Cordis (Miami Lakes, Florida) for the Cypher trials was subacute closure, unexplained death or myocardial infarction (MI) associated with Q-wave aberrations as seen on an electrocardiogram. The firm’s definition for ST out to 360 days was infarction later than 30 days after the procedure that is attributed to the target vessel when accompanied by angiographic documented.
For its Taxus trials, Boston Scientific (Natick, Massachusetts) defined ST as any one of the following three: clinical presentation of acute coronary syndrome with angiographic evidence; acute MI in the distribution of the treated vessel; or death within the first 30 days if no other cause is discerned in the absence of an autopsy.
Part of the controversy here is that industry sponsored the ARC effort with, reportedly, a $10,000 donation to house and feed the effort, and the Cleveland Clinic’s Steve Nissen said he had “a problem with” such an arrangement. The panel chair, William Maisel, who makes his rounds as an MD at Beth Deaconess Hospital in Boston, termed it “an imagination” to expect to get patient level data from industry for nothing.
— Mark McCarty, MDD Washington Editor