Derek Lowe's take on this, probably written before those HHS comments, was that "the agency appears to have signed off on the trial design as proposed, and I can’t see Moderna going ahead with it if the agency had done otherwise". Does it appear that the design was actually approved?
Those communications are not public. So we don't know, we only know what each side is saying: FDA says they gave clear guidance, while Moderna claims they were not told a high-dose comparator was required for 65+, which is perhaps another way of saying "you gave guidance that left room for interpretation," which frankly is not an argument that flies with any regulator anywhere, although it can be very frustrating for companies. At any rate there is active dialogue between FDA and Moderna, and if they refile anything could happen
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Derek Lowe's take on this, probably written before those HHS comments, was that "the agency appears to have signed off on the trial design as proposed, and I can’t see Moderna going ahead with it if the agency had done otherwise". Does it appear that the design was actually approved?
https://www.science.org/content/blog-post/mrna-refusal-file
Those communications are not public. So we don't know, we only know what each side is saying: FDA says they gave clear guidance, while Moderna claims they were not told a high-dose comparator was required for 65+, which is perhaps another way of saying "you gave guidance that left room for interpretation," which frankly is not an argument that flies with any regulator anywhere, although it can be very frustrating for companies. At any rate there is active dialogue between FDA and Moderna, and if they refile anything could happen