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biopharm

08/11/14 6:04 PM

#186174 RE: Protector #186165

N. Review by the Competent Authority or Ethics Committee in the country concerned
N. Competent Authority Decision Authorised
N. Date of Competent Authority Decision 2014-03-17
N. Ethics Committee Opinion of the trial application Favourable
N. Ethics Committee Opinion: Reason(s) for unfavourable opinion
N. Date of Ethics Committee Opinion 2014-07-04

https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003953-13/IT



thanks for the Italy link re: n=55 they have planned, and I did notice that the Date of Competent Authority Decision was back in March of 2014. Again, another date back to March of 2014.... but CP, do you or anyone else even... know what material or data..etc is utilized/available to base this "favorable" decision that the Ethics Committee Opinion made. Basically.... do they have any access to current Phase III SunRise data? or simply the phase IIb NSCLC data that Peregrine submits to the FDA .... ? or... ?