(Total Views: 577)
Posted On: 01/21/2021 12:14:44 PM
Post# of 148924
Here is the conversation in chronological order from Twitter without the spin & commentary by Citronsource, a known short.
https://mobile.twitter.com/brucep13/status/13...2878671872
T Penn
@TPenn39777458
Replying to @brucep13
Perhaps it would help if Bruce would clarify why the relationship cooled with Cytodyn once and for all, so everyone can stop speculating. I've never heard Nader say one bad word about Bruce, or IncellDX. What say you @brucep13? What is the truth?
7:55 AM · Jan 20, 2021·Twitter Web App
brucep
@brucep13
You don’t think blaming the BLA delay on IncellDx’s RO assay when we didn’t even run it in the combo trial and only a third of the mono trial is bad? It is so critical in all CCR5 trials because of the variation in CCR5 level day to day.
9:13 AM · Jan 20, 2021·Twitter for iPhone
misiu143
@alicja48
Replying to @TPenn39777458 and @brucep13
When combo study was going on , there was no Receptor Occupancy Test .
It started sometimes second part of mono study ..
Why FDA is asking for it in combo after all this time , no one will know ..
IMO
10:35 AM · Jan 20, 2021·Twitter Web App
brucep
@brucep13
Personally and knowing the FDA from the Maraviroc and Vicriviroc trials in the early 2000’s, I think they have questions about the tropism assay that qualifies a patient for CCR5 therapy. Tropism assays are highly variable and confounding
10:48 AM · Jan 20, 2021·Twitter for iPhone
https://mobile.twitter.com/brucep13/status/13...2878671872
T Penn
@TPenn39777458
Replying to @brucep13
Perhaps it would help if Bruce would clarify why the relationship cooled with Cytodyn once and for all, so everyone can stop speculating. I've never heard Nader say one bad word about Bruce, or IncellDX. What say you @brucep13? What is the truth?
7:55 AM · Jan 20, 2021·Twitter Web App
brucep
@brucep13
You don’t think blaming the BLA delay on IncellDx’s RO assay when we didn’t even run it in the combo trial and only a third of the mono trial is bad? It is so critical in all CCR5 trials because of the variation in CCR5 level day to day.
9:13 AM · Jan 20, 2021·Twitter for iPhone
misiu143
@alicja48
Replying to @TPenn39777458 and @brucep13
When combo study was going on , there was no Receptor Occupancy Test .
It started sometimes second part of mono study ..
Why FDA is asking for it in combo after all this time , no one will know ..
IMO
10:35 AM · Jan 20, 2021·Twitter Web App
brucep
@brucep13
Personally and knowing the FDA from the Maraviroc and Vicriviroc trials in the early 2000’s, I think they have questions about the tropism assay that qualifies a patient for CCR5 therapy. Tropism assays are highly variable and confounding
10:48 AM · Jan 20, 2021·Twitter for iPhone
(7)
(0)Scroll down for more posts ▼
