Vertex's R&D team maps a straight course to the FDA as it lays out pivotal search for another blockbuster
Vertex has been signaling for some time that it has high hopes for VX-147, an experimental drug that has demonstrated a clear hit on proteinuria in a small study. So it didn’t come as a huge surprise that the company has now mapped out its plans to hustle up an accelerated approval based on a 48-week interim analysis of a new Phase II/Phase III pivotal program.
Not all the analysts watching this prospective blockbuster are all on board with every aspect of the trial design, but you can also sense that this is one of those big, blockbuster programs that will be watched intently at every turn.
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