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Sunday, August 26, 2018 12:24:16 PM
1. Your first link is about reporting rules for NIH funded clinical trials only.
2. From LR's link (underline mine):
Typically, a duty to disclose arises out of one of two scenarios. In the first, there is a statute or regulation that mandates disclosure such as the line items in a current report on Form 8-K or under Regulation FD. In the second, disclosure is required to avoid rendering existing statements misleading such as in connection with an offering and sale of securities. As a general principle, absent one of these scenario or under other limited circumstances, there is no affirmative duty to disclose material information simply because it exists.
3. Things don't seem to be different even when communications with FDA are considered. For instance, this study found that 18 % of FDA's CRLs (Complete Responses Letter, weird name for FDA's decision to reject drug application) did not get any press release out of the receiving company (silence), 21 % of press releases did not match anything in the CRL (creative interpretation... ahem... lying) ...
"I would rather have questions that can't be answered than answers that can't be questioned." Richard P. Feynman
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