(Total Views: 494)
Posted On: 09/17/2019 12:25:53 PM
Post# of 154977
I just listened to this part from our shareholder meeting..
It is 24:30-to about 28 minutes..
FDA is " adamant " to give as approval of HIV combo and mono..
At this time I will say what SJ said , I will believe when I see it ,
I believe that for whatever reasons they delayed CYDY for few years now. but this is just IMO...
Anyway Dr NP read a letter from meeting with FDA...
They want now data with 700 mg for combo , they will have this end of October,
but problem is with stabilities , CMC , FDA want 6 months , which will be in March, but they negotiated 3 months , so end of NOVEMBER , and they will report in December...
But they applying immediately for BTD , and if they will get it , all be done end of October.
Approval either way around Q2 of 2020. ( 1 or 2 months either way )
It is 24:30-to about 28 minutes..
FDA is " adamant " to give as approval of HIV combo and mono..
At this time I will say what SJ said , I will believe when I see it ,
I believe that for whatever reasons they delayed CYDY for few years now. but this is just IMO...
Anyway Dr NP read a letter from meeting with FDA...
They want now data with 700 mg for combo , they will have this end of October,
but problem is with stabilities , CMC , FDA want 6 months , which will be in March, but they negotiated 3 months , so end of NOVEMBER , and they will report in December...
But they applying immediately for BTD , and if they will get it , all be done end of October.
Approval either way around Q2 of 2020. ( 1 or 2 months either way )
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