100% agree with your balanced and reasoned response, Buckeyes.  

https://www.fda.gov/drugs/data-standards-manual-monographs/phase-4-commitment-category

"Phase 4 studies are post-marketing studies that are imposed upon a pharmaceutical firm as a condition for drug approval."

A mear month after reviewing BetOnMace, the FDA announced they want to loosen criteria to approve drugs for serious conditions.  If you read the proposals, which they specifically state are reflecting their current thinking, BetOnMace would receive immediate approval, and possibly with the condition of a Phase 4 which would be the worst case scenario under the new guidelines.

Anyone suggesting that a new Phase 3 trial will be required is presumably of the opinion that the FDA's current thinking will not be applied to the evaluation of BetOnMace.  https://www.fda.gov/media/133660/download

 JMHO