EMD Approvals / Production

Hi all,

I'm a first time poster and rookie in the market, so be gentle.

I'm holding EMD stocks and acquiring more.

I have looked at a lot of the data posted on here and from external sites.This company looks awesome with their trials results and possible place in a massive market, locally and internationally. The only thing I'm weary about is the FDA / TGA approvals and keeping up with production if approval given. I work for a company supplying orthopaedic implants and understand the difficulty getting these approvals and rebates through the governing channels.

Do you have any insight or opinions on these concerns?? and where do you see this company headed if their products hit the market and seeing Jazz at the SP currently?

Thanks hope this was ok to post.