@Biobonic, thanks. We'd need to hire a lawyer to decipher this, but this verbiage is interesting. Makes it sound like the 4/15 "Study Completion Date", aside from being optional, might allow for potential modifications that improve the data but can't reduce it. I wonder if this indicates they found something unexpectedly positive & got authorization to modify some study requirements? Hence the additional delay. Of course this is very loose dot connecting, because I don't have my jibberish decoder ring on.
Section 402(j)(2)(A)(ii) of the PHS Act specifies the clinical trial registration information that must be submitted, although study completion date is not included. However, section 402(j)(2)(A)(iii) of the PHS Act permits the Secretary to “modify the requirements for clinical trial [registration] information” by regulation, provided that “such a modification improves and does not reduce such clinical trial information.” Start Printed Page 65029As discussed in Section IV.B.4, we believe that the study completion date is helpful in indicating when all primary and secondary outcome measures and the collection of all adverse event information, as specified in the protocol, will be completed and when final data collection has occurred. Therefore, we believe that requiring the submission of the study completion date improves and does not reduce clinical trial information.
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