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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