Ann: Quarterly Activities/Appendix 4C Cash Flow Report, page-92

All anyone wanted was a simple 'we are following the plan as laid out in our meetings with the FDA'

Not muddied waters with 'we were going to do an adult trial but now we will go with off-label and cancel the planned trial'

Depending on your position then either the FDA have explicitly laid out to MSB that, yes, off-label will be a certainty after paediatric approval OR

'SI is a dickhead and has gone rogue again, doing what he wants and not listening to the FDA'

After all the failures before, you can see why this latest and seemingly unnecessary changing of dialogue is clearly upsetting some LTH's.

Keep It Simple Stupid, sometimes, is the better choice.

All indicators were overwhelmingly positive before, and now, this last minute change of plan is creating doubt in some, where there was none before.

Seems daft to me, and pointless.