The question of dosage was a concern and remains so until we...

The question of dosage was a concern and remains so until we hear from the FDA that it has been resolved. The optimal dosage amount should have been finalized in testing escalating doses in Reach2HD Phase II which was limited to only two variations: 100 mg and 250 mg. Prana did not bring up the matter of considering a higher dosage in clinical trials to ensure efficacy until after completion of Phase II. It's understandable that they would want to try a higher dose (ie perhaps 2x/day?) considering the less than stellar results of the multiple secondary outcomes.

They say that they have evidence of safe higher dosages in the past - but they DID NOT use them in the FDA Phase II. It's not too hard to understand the FDA's reticence to proceed to Phase III. They could have asked for another Phase IIb with higher doses before progressing to a more complicated Phase III. That certainly wouldn't have taken longer than the PCH has turned out to be.