What is going on, page-11

Looking at the approval process in a cynical way.

Causing delays to approval takes the risk out of the approval from the CHMP side. The product trials as part of the health economics continue in Germany and the UK. If any problems are likely to arise it will be when the product is first used. So delaying approval reduces their risk and and they look like they are doing a very robust check prior to approval.

There is no cost to them in delaying medicine approval only political cost in approving to quickly like the artifical hip, breast implants etc.

This is the reason for having set a time limit to process the application. Unfortunately when you add stop clocks and other delays it is a very slow process.

Having said that approvals act as a barrier to entry and an approved medicine inside patent can be a very profitable monopoly. For a viable medicine the trick is getting to start of sales.