scandal, page-7

TIS management are 100% to blame here.
The final form of the product has been known for years, and therefore they should have sought clarification of its Regulatory status years ago.
Its not rocket science, how hard is it to plan a critical path to approval, that ensures as many tasks as possible are undertaken in parellel rather than sequentially.

Had they taken this approach the product would be listed now.

Absolutely no excuses here - management has stuffed up big time.