Wednesday, January 13, 2021 2:31:29 PM
Company looking for acceptance and as high as possible priority for a publication in a prestigious journal for the medical community. You mentioned in a previous post that they don't need journal acceptance to release basic TLD and I agree with that, but the opposite could happen. If the company just publishes TLD as soon as possible without any strategy, publication may be not approved or not prioritized by a prestigious journal.
I also think that it is the reason for not having new end point information updated with the FDA (clinicaltrials,gov information is updated by the company) and having it updated in the UK and Germany (information is not updated by the company, but by the regulatory entities). Look at the extracts of the document where it mentions government agencies.
I also strongly believe that trial outcome is positive, because otherwise the company would not be so interested in getting the journal publication and they would be at risk of having legal consequences for not reporting earlier if results were bad.
Below are some extracts of the document Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals (updated December 2019) published by the International Committee of Medical Journal Editors (ICMJE) that support what I'm mentioning. Take a look at the whole document if you like, to these extracts, or to what is in bold, specially red bold.
Link to the document mentioned: http://www.icmje.org/icmje-recommendations.pdf
Also take a look at the amount and names of journals that follow ICMJE. Link to ICMJE webpage: http://www.icmje.org/
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