Here is quick summary from AI
So I don’t know what do you want FDA , you want FDA to do something they don’t do , and that too for a small , practically unknown company on an OTC , before company agrees to submit a formal application :
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“🔹 The FDA does not “approve” a Statistical Analysis Plan (SAP) in the sense of issuing a formal approval letter like it does for a drug or device marketing application. Instead:
✅ FDA reviews and accepts the SAP as part of the overall trial protocol during the Investigational New Drug (IND) or Biologics License Application (BLA) process.
✅ The SAP becomes a binding part of the trial protocol that sponsors must follow once agreed with the FDA.
✅ If the SAP is modified after initial agreement, significant changes may require protocol amendments, which the FDA must again review and accept.
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🚫 But the FDA does not grant an “SAP approval” certificate or decision. There’s no official “stamp of approval” issued specifically for the SAP alone.
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🔎 What happens in practice:
• Sponsors typically submit their SAP as part of their trial protocol or as a separate document during the IND phase.
• The FDA may provide comments, request clarifications, or recommend changes.
• Once the sponsor addresses these, the FDA’s acceptance effectively indicates that the plan is adequate for evaluating trial data, but not formally “approved.”
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📌 Key takeaway:
The FDA’s role is to accept an SAP as adequate for the trial’s intended endpoints, but it does not approve SAPs as standalone regulatory actions.”
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