RE:RE:RE:RE:RE:RE:RE:RE:Phase11 450 days CR% data for BTD approval in Dec 2022...
I'm not sure why anything needs to be somber. The CR is moving up nicely. While some are discouraged that the 12 undertreated are weighing down the CR%, it strikes me that BTD doesn't have the same standard as a full APPROVAL. The FDA can look at the data and give BTD without risking accidentally approving something too early. Hopefully the full story of what has happened with the undertreated will factor in the decision.
I wonder if a company can contact your FDA liason and just say, "hey, should we submit this many with this CR and PR or should we wait for a few more patients?" You would think that the system would work best if there was some easy dialog about these things. IMO