“We are confident that this data will be sufficient for EU approval for sale (CE Mark). The final piece we need for CE Mark is the validation data from our new, larger scale manufacturing process and this will be available during December 2011.”
If the validation data was to be available in December, one would think the application would have been submitted or very close to being submitted...and they're talking an accelerated (45 day) examination. Which would put us to end Jan at best, sometime in Feb otherwise. All in time for a Q2 start to sales.
Playing devils advocate for a bit: Considering the confidence management had of signing a deal in Q1 2010 and the confidence/expert advice that they would get FDA Device classification - how sure can we be that the validation data won't be delayed or that the existing trials data is not sufficient for EU approval??
It'll be interesting to see how things hold up if we have to wait till mid to late Feb for the next ann.
Regards
DYOR
GLTA
“We are confident that this data will be sufficient for EU...
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