who cares FDA datafarer?? We already got UK and Germany accepted the New Endpoints. Did you not see the regitrylinks that senti shared with us today? And when UK approves DcVaxL, FDA will approve too like they seconded themselves in the approval of the Pfizer vaccine. Stop FUDing on FDA.
FDA issued guidance on this. The FDA is looking for support from the medical and science community for the guidance. So I don't think the issue is the FDA, it is having support from the industry leaders that the FDA looks to for cover when it makes a major change, as it did with its updated guidance, upon which the SAP is based.
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