Managed Access

Before you read this post: I’m about to weave a long story that might take 20 – 30 minutes to read. I start with recent good news before walking us back to 1953 and some phenomenal science that followed to allow this good news. Next, I add a ‘crash course’ that covers the steps from drug discovery and development through to clinical trials, regulatory submission and approval to commercial marketing. I’ll gloss over some things to simplify, but I do cover a lot, so read on at your own discretion. Some good news On June 12, 2024, I joined a group of patients in getting early access to a new medication not yet approved anywhere but submitted to multiple health agencies for anticipated regulatory decision in August. It might sound familiar because I wrote about the February 20, 2024 regulatory submission in an earlier post . After pre-clinical work and results from Phase I and II trials, efficacy results from the Phase III ‘Indigo’ Clinical Trial showed tha...