spark upwards.............., page-24

re: more bad news I wasn't worried about the hiccup? with the Aust authorities but when we start talking about new clinical data required by the FDA you are talking months and months because clinical data takes time. Something seriously wrong with the news conveyed to investors over the last 4 to 5 months as you would have thought CCE would access the best advice to make sure all bases are covered and for approvals to be processed without these sort of real obstacles:
"The performance data requested to determine ‘substantial equivalence’ will be derived from
a clinical study, the details of which will be determined after discussions with the FDA.
Guidance on the performance data required has already been provided by the FDA and
includes additional clinical assessment of graft loss, scarring, infection and time to
complete epithelialisation (wound closure)."
Hell it will take CCE and the FDA probadly 3 months to decide on what the clinical study should be anyhow - lost me now!