Reasons for the delay were/are FDA deciding on
Post# of 154115
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Posted On: 02/15/2020 10:47:15 AM
Reasons for the delay were/are
FDA deciding on 525 vs 700mg late December
FDA demanding 700mg stability data
FDA demanding all data (safety+efficacy) from 600 patients in mono trial to randomly pick data from 50 patients
All of which is causing AMAREX und AGC to need more time to compile/transfer data.
BLA is priority no. 1. If they wanted to intentionally delay BLA - which is absurd - they'd need to announce it and couldn't lie about it. Apart from this, everymonth without BLA costs us a lot of money because of the contracts and preparations.
So, no.
FDA deciding on 525 vs 700mg late December
FDA demanding 700mg stability data
FDA demanding all data (safety+efficacy) from 600 patients in mono trial to randomly pick data from 50 patients
All of which is causing AMAREX und AGC to need more time to compile/transfer data.
BLA is priority no. 1. If they wanted to intentionally delay BLA - which is absurd - they'd need to announce it and couldn't lie about it. Apart from this, everymonth without BLA costs us a lot of money because of the contracts and preparations.
So, no.
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