CHMP Meeting, page-39

Re-oral procedure: we seem to have all bases covered. 1) Scientific - the product has proved to be effective in numerous trials 2) The manufacturing process is being handled by a top EUROPEAN company with many years expoerience and which is licensed to both EMA and FDA quality standards.
It would require the most remote, obscure or deliberately obstructive question to defeat our team and result in rejection. I was out buying again yesterday.