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Tuesday, February 01, 2022 11:46:59 AM
Does a journal restrict a company from releasing TLD prior to publication? No, as long as it is a brief description.
If the answer is no despite what the company has put out, then why withhold TLD? My working assumption is that the advisors felt the TLD results could not be adequately appreciated without more context than could be provided in a normal brief TLD release. I think they felt that releasing TLD simultaneously with a publication that provided a high level of detail would help the results be received more favorably. That is not a bad thing.
Is the FDA influenced by a journal publication? By how much would the FDA be influenced? The FDA does not really care about the publication itself, but only the underlying data. The FDA is providing its own "peer review," and in much more detail than an journal reviewer could provide (a reviewer would never see the underlying data that statistics are based on, but the FDA would).
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