I think the perfect move would be to replace Don with a younger experienced energetic CEO who has shown the ability to lead a late stage drug across the finish line. Don should stay involved though, maybe on the BoD or an official advisory role for continuity while acquiring more asseritve and productive leadership.

A complete "about face" or change of direction is disconcertive to many. But adding new and properly algned and experienced leadership with a track record in our field can be viewed as a natural progression and accretive move rather than just a "punt" and starting over ... and more poor optics like "let's just take a swing in a different direction and throw new mud against the wall and hope it works."

Definitely time for change and a higher quality of leadership to get to the finish line. Happens all the time with entrepreneurial ventures and start ups as they advance, and need diferent styles and concepts from initial vision to the commercialized market.