Yes, Capricor Has A Defence

And Yes, It Is Better Than The Market Thinks

This will be a "best ideas only" bio Substack providing actionable, highly digestible and high conviction value to investors focused on quality not quantity. Disclaimer: Nothing in this article (or Substack) is considered investment advice and is solely the opinion of the author.

One of the easiest mistakes to make in biotech investing is to confuse an FDA briefing document with the final truth. Briefing books are extraordinarily valuable because they show us how reviewers are thinking and where they believe the weaknesses in an application lie. They deserve to be read carefully but they are not judicial opinions, nor are they the final position of the agency. They are one side of a regulatory argument that will ultimately play out before an advisory committee and, eventually, the FDA itself.