Under any path forward there should be no confusion about the need for a BLA to be filed as requisite for commercial license approval by FDA in the US market. He is challenging the wording used that implies separate pathways independent of BLA submission and approval. That is exwannabe’s main point in the post you are responding to and I support that point of clarification being made in spite of the fact that many other comments made by him are not supported by me as anyone reading my posts over the years might obviously see; ). Best wishes.
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