Per Dr NP , FDA answered them but also added some
Post# of 153897
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Posted On: 04/14/2020 10:46:06 AM
Re: reallypeople? #27444
Per Dr NP , FDA answered them but also added some extra things to be provided to them, and this what again took extra time..
This is a dance with FDA going on , as patients with MDR in HIV dying ,
Since February 2019....
-- when CYDY finished successfully phase 3 combo with 81% efficacy with 350 mg dose....Not one severe serious side effect.
--Maraviroc was approved with 45% efficacy,... with all the severe side effects..
--Ibalizumab was approved with 43% efficacy. ....Also with many side effects and IV treatment..
But being that FDA appreciate all the great results and not one serious side effect , it is almost May 2020 and we dont even have BLA done , because they really see the great results , just every few weeks need tiny bit more information....
All IMO.
This is a dance with FDA going on , as patients with MDR in HIV dying ,
Since February 2019....
-- when CYDY finished successfully phase 3 combo with 81% efficacy with 350 mg dose....Not one severe serious side effect.
--Maraviroc was approved with 45% efficacy,... with all the severe side effects..
--Ibalizumab was approved with 43% efficacy. ....Also with many side effects and IV treatment..
But being that FDA appreciate all the great results and not one serious side effect , it is almost May 2020 and we dont even have BLA done , because they really see the great results , just every few weeks need tiny bit more information....
All IMO.
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