"They will most likely agree on a new Phase 3 trial with "requested changes"."

Hi iconoclast,

Are you completely dismissing the possibility of an accelerated approval under the new FDA proposed guidelines for unmet needs in serious diseases?  BetOnMACE would get a passing mark under the FDA's own proposed new yardstick.

Further, in the face of the drug's outstanding safety profile are you still completely dismissing the possibility of immediate FDA marketing approval conditional to start of a Phase 4 trial?

Also, why would the company description in all recent NRs include the statement "..a time-efficient drug development program including planned clinical trials and plans for expediting the manufacturing development strategy." ? 

Sounds 'Phase 4ish', no?  Otherwise it would seem way premature to be talking about expediting manufactoring capacity if they had an entire P3 trial to re-do first.