I am thinking that our BTD process will be accepte
Post# of 155484
(Total Views: 931)
Posted On: 11/16/2021 1:57:07 AM
I am thinking that our BTD process will be accepted more early than late. Why would the FDA wait the full 60 days after seeing the results when people are dying and Leronlimab can save lives? I am betting that the FDA is under 30 days accepting our BTD application and a few A meetings between now and the 30 days. Just to see all the data as it is occurring.
Things are looking real good for a quick approval in my opinion. The results are undeniable and tell the whole story. They can not be ignored. Finally we have results that shine bright and are huge.
I see the FDA assigning a whole team to help Cytodyn format their BLA application for mTNBC in the 5 proper sections in a short time. We could have an approval as soon as 3 months or as long as 8 months but I am hoping for the 3 months. It’s what feels right for the FDA to do to make things right. We know they need to show up on this one.
Wouldn’t it be great to see the 13d/shorts have to eat crow when Nader shows his great relationship with the FDA and shines and they knock out this BLA in the bare minimum record time… that would be awesome!!! Of coarse this is my opinion of how things should go. We shall see how they really go…
Things are looking real good for a quick approval in my opinion. The results are undeniable and tell the whole story. They can not be ignored. Finally we have results that shine bright and are huge.
I see the FDA assigning a whole team to help Cytodyn format their BLA application for mTNBC in the 5 proper sections in a short time. We could have an approval as soon as 3 months or as long as 8 months but I am hoping for the 3 months. It’s what feels right for the FDA to do to make things right. We know they need to show up on this one.
Wouldn’t it be great to see the 13d/shorts have to eat crow when Nader shows his great relationship with the FDA and shines and they knock out this BLA in the bare minimum record time… that would be awesome!!! Of coarse this is my opinion of how things should go. We shall see how they really go…
(6)
(1)