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Monday, August 09, 2021 2:36:47 PM
anders the one-year FDA disclosure period has not expired as the final data was obtained on October 5. I don’t recall thermo’s turn of phrase but I am confident of this statement. Also, and I am not aware of the specifics, other informed persons on this Board opine that this rule is subject to exceptions and/or interpretation. I express no opinion on that view.
Uhm, first the rule does not apply if the company asserts they are planning on filing a BLA for a previously unapproved product.
Second, the clock starts with the last data collection from a patient, not the data lock. We do not know when that was, but certainly well over a year ago.
Third, this is the same body of law that LP has violated for years. There is basically no enforcement.
OH, and one just for fun. It does not apply if the primary completion date was pre Jan 17, 2017. And what exactly does the US trial registry state on that subject?
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