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Re: hitekmastr post# 118128

Monday, 09/21/2020 3:55:11 PM

Monday, September 21, 2020 3:55:11 PM

Post# of 236704
If CYDY submitted the much delayed BLA in April after achieving fast track status and more advice and assistance by FDA - Then had to amend the submission with omitted information by May 11, then after receiving the RTF in July, assured us that this would be easy to reverse as the efficacy data and info on the syringes was readily available, then decided more consultations with FDA were needed to exchange questions via email - then decided that a direct, real time meeting with the FDA was needed - weren’t you just thrilled that on September 8 Kush Dhody had a wonderful meeting with FDA where he learned what was needed to include in the submission to FDA.
Can’t make this up!
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