If that is the case why didn't tis meet with scientific committee and agree on method and resulting data required rather than spending months on a blind goose chase doing stuff with manufacturer which has now been deemed unsuitable? Something doesn't add up with the story or they didn't get suitable undertaking or come good with correct data. To have to now lock down exact process, data,format, trial or whatever is again 9 months late and wasted
Why didn't tis access the committee 9 months ago to get clear direction and confirm approval pathway data?
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