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Re: theswordman post# 228758

Monday, 01/08/2024 5:10:23 PM

Monday, January 08, 2024 5:10:23 PM

Post# of 233530
Phase II you say? This little tidbit regarding a previous FDA statement on leronsaline look familiar?

(2) Clinical hold of a Phase 2 or 3 study under an IND. FDA may place a proposed or ongoing Phase 2 or 3 investigation on clinical hold if it finds that:
(iv) The drug has been studied in one or more adequate and well-controlled investigations that strongly suggest lack of effectiveness;
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=312.42#:~:text=A%20clinical%20hold%20is%20an%20order%20issued%20by,subjects%20may%20not%20be%20given%20the%20investigational%20drug.


Dredging up some circus side show characters and calling it a "new" protocol aint gonna cut it.
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