Ongoing discussions with FDA and MHRA. Probably just ironing out the finer details. Coincidentally and conveniently may carry on till interim s/c results are available.

All signs point to approval about the same time S/C is out, imo.

Now, lets see who plays the better game over the rest of September. The sharks shorting the stock or the whales taking positions to launch the sharks out of the ocean and into an erupting volcano.