dennisdave,
No it’s not. FDA does not “approve” the SAP until it approves it as utilized in a BLA. This leaves everything up to subjective action regarding the ECAs. Those insisting that ECAs be based on patient level data, even when the guidance allows for consideration of other measures, know the BLA could be approved using measures that NWBO submitted to MHRA with but they are also easily opposed just as you state because of FDA’s stated preference that ECAs be based on patient level data. Linda isn’t going to fall into that trap until FDA clearly states that they will approve what NWBO has to offer especially after they interfered with the trial design because of leukapheresis being considered an invasive procedure which led to a crossover requirement and OS confoundment with it and the screening halt which reduced the powering of the trial. In the mean time, manufacturing will have a chance to catch up to expected US demand when an approval does come after FDA’s hand is forced by approvals elsewhere. Best wishes.
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