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Friday, March 18, 2022 1:31:39 PM
That’s not likely what is going on and they did not have to “sell” it, it would sell itself. The regulatory changes are in process and the complexities of the trial are well known. There are likely very clear cut regulatory related issues that actually define the success of the trial and journals like solid circumstances. I believe they can resolve the matter with either final guidelines or an approval. Journals likely would not want to be far out ahead of a regulator on these issues with regard to a specific trial. Arguing vague policy is one thing, abstractly. But this is a specific case.
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