Arch Therapeutics Inc (ARTH)

[jsmith123343]

Does anyone know how long CE mark takes ? I read that PMA approval takes about 180 days. My guess is CEO is going to apply for both CE and PMA once results are out. CE looks more at safety, and FDA looks at safety and efficacy. Which is why they are doing the trails...to show both.

Does anyone know if this will be classified as class II or class III ? Thinking it is class II. Class II gets FDA approval much quicker than 180 days..could be 1-2 months.

Look at examples, this definitely seems to be class II -
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm