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Re: biosectinvestor post# 375232

Saturday, 05/08/2021 12:17:28 PM

Saturday, May 08, 2021 12:17:28 PM

Post# of 824214
Provide a link + quote to and from a reliable resource where your opinion is based on ANY fact!

This is the FDA

Failure to report the results of a clinical trial can distort the evidence base for clinical practice, breaches researchers' ethical obligations to participants, and represents an important source of research waste. The Food and Drug Administration Amendments Act (FDAAA) of 2007 now requires sponsors of applicable trials to report their results directly onto ClinicalTrials.gov within 1 year of completion. The first trials covered by the Final Rule of this act became due to report results in January, 2018. In this cohort study, we set out to assess compliance



This is your opinion:

It is not something that any regulatory agency at this moment is charged with enforcing and for which there is no strict enforcement.



By the way, it was you who claimed that NWBO could only be fined with monetary penalties for not updating trial results 12 months after study completion the consequences are just a little harsher as you claimed, consequences are:

a. criminal judicial actions
b. civil monetary penalty actions
c. grant funding actions
d. Failure to report the results of a clinical trial can distort the evidence base for clinical practice


For not enforcing they sure have a lot of penalties!
NOT updating the trial results within 12 months after study completion is a criminal offense end of story

Only 10% of all burglaries are solved, does this now mean one has permission to break into a home? Even if the FDA does not act to uphold their own rules, which no one has proven here, then still that does not mean one can break FDA law, regs, or rules.

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