roche pma interesting , page-31

I'd like to re-iterate the point that every one of these tests that talk about approval for changes to the manufacturing also have preceding notices about moving the manufacturing to the Mannheim facility in Germany.

Over the last few years Roche has been undertaking "Operation Excellence" that aims to reduce costs, partly by streamlining manufacturing processes. These tests are likely to have modified manufacturing processes as part of this internal efficiency program.

Sure, it could be Mix&Go - and hopefully it is, but I'd be cautious in putting too much weight on this information for now.

Now, on the converse side, something else I've noticed is in ADO's May presentation it was stated:

ADO is currently working on supply agreements with leading global IVD players

The date of application for these PMA's is in August - 3 months later. So perhaps Roche reached a commercial supply agreement with ADO in June/July pending successful PMA approval and stability testing? They started stability testing in June/July which the first 6 months will be up shortly - which will make the contract valid as PMA approval has now been received.

There is certainly a number of dots that "appear" to line up, but I'm fully invested and happy to wait. It really is just a matter of time, but it's fun to guess in the mean time :)