It could be a number of things. Something simple would be nice...

It could be a number of things. Something simple would be nice however with TIS nothing seems to be simple

Part of me wonders whether the CHMP just don't like our product. They already tried to classify it as a medicine once, and may have lingering resentment towards being over-ruled as a result of the court case. I am also frustrated at the fact that there is no process for continual questions and answers within the review process. It just serves to slow it down a lot more.

I am hopeful that as we did all the work on our manufacturing processes, we have the data that they need and can reply to their questions quickly.