ITM....partial hold IMO, page-2

This is the explanation from the half yearly report:

Prana doesn't appear to be proposing a different dose from the Phase II REACH2HD trial, rather it appears that the FDA spotted something in the animal trials that caused them some concern. My personal view (speculation) is that Prana has requested accelerated approval for HD and the FDA is being ultra-conservative because they know that, if approved, PBT2 would be subject to an enormous amount of off-label use for AD. Reading between the lines, I think the options open to Prana are:
a) conduct the phase III trial at 250mg per day, but monitor X (whatever the FDA is concerned about) - but this trial would need to be undertaken before FDA approval, or
b) conduct additional animal trials to alleviate the concern about X, and if OK then accelerated approval can be granted.
Unfortunately both of these options take time (I'd assume the second is faster, but it is a risk. The mice might not do as we would want).
My next best hope is that Europe doesn't care about X and is prepared to approve PBT2 for HD there.
I'm still mightily f*ed off at Prana for their lack of communication on the situation and their options.