Worst Case Consideration, page-4

There are trial risks such as AEs or not meeting endpoints - but those aren’t the things that worry me to be honest. For me, the concerns are about what happens afterwards. Execution risk. I’m one of those who have stuck up for PR and management in the past (mostly because I felt the criticism was overblown, and paled in comparison to the things they’d gotten right) but there is a lot of risk contained in their partner strategy, the deals they strike, the companies they strike them with - and in keeping Bene happy, so the supply deal operates faultlessly (i.e is watertight, the way it has been sold / portrayed to the market so far).

How long will it take post-approval to get it to market, and can we build meaningful market share before other competitors or treatments emerge? Will they be in a position to make the most of the 3-year regulatory exclusivity to establish themselves as the dominant market leader? What if the FDA fast-track another PPS manufacturer within, say, 5 years and we’ve stuffed around and made errors due to a poor partnership choice, or other decisions made poorly due to…you name it….ego, pride, inexperience, or any other hubristic flaw that can afflict human beings when they believe the world is at their feet.

There is so much that we need to get right, even after trials. Getting the first deal over the line (for whatever indication) will be huge for me. Getting the major OA deal (USA and Europe) done from a position of strength, and getting a good feeling in your guts about it, will be massive. If the company can nail that deal, we should be set for life. Even then, though, we need to see sales going the way we hope. We are still at the very beginning in many ways. I don’t know I also really want to hear more from Bene, and about our supply deal. There’s really so much grey when we look to the (quite near) future.