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CytoDyn Inc CYDY
(Total Views: 395)
Posted On: 02/15/2020 10:47:15 AM
Post# of 155005
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Posted By: lorbas
Re: RTB #18428
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.














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