RE: for those who think Chan and companyTort,
It's a daunting document, nonetheless it is part of the work that all companies wishing to be lisited must undertake. You should see the FDA protocols. If you look at the MIR website under "leadership" you will find that almost none of the listed leaders have any pharmaceutical or diagnostic sales/ marketing experience, except for Dick Van Manaan. And Dick only recently joined the company. On top of that I think it isn't within his area of expertise to comply with agency rules/regulations. That falls on Robyn, I believe. Seems to me that she comes straight from academia with a small amount of experience with an oil company, not sure how that relates to regulatory affairs. "Robyn is responsible for overseeing MedMira's compliance with externalregulatory bodies and managing the Company's Quality Systems andRegulatory Affairs". Pharmaceutical/diagnostic companies frequently have a liaison officer who continuously/frequently monitors the progress of approval and interacts (lobbying) for speedy results. MIR is has some very cutting edge products but a less than enlightened management for the business side. It's not enough to simply advance a dossier per agency rules and regulations, there has to be concerted follow up and lobbying. If I were them I would do my utmost to contact each and every decision maker on the WHO decision body and lobby them positively. I am up for the job (27 yrs experience in pharmaceutical industry).