Replies to post #17107 on Cytodyn Inc (CYDY)

[misiu143]

Trading - hmm this is exactly how I feel that they have a list of this patients .

[finesand]

Changes to NCT02483078, FDA Meetings & Delays

2017_08_30 Changes:
- Recruiting 2016-11 -> 2017-08
- last_follow_up_date 2018-08 -> 2019-08
- primary_compl_date 2017-08 -> 2018-08
- dropped <design>Safety/Efficacy Study</design> tag
- dropped <safety_issue>Yes</safety_issue> tag
- dropped <regulatory_authority>FDA...</regulatory_authority>
- added empty <fda_regulated_drug>..

Dropped Exclusion:
- Prior use of maraviroc or any other CCR5 co-receptor antagonist

2017_09_05 Changes:
- Recruiting 2017-08 -> 2017-09
- last_follow_up_date 2019-08 -> 2018-04
- primary_compl_date 2018-08 -> 2017-10

Effective Date Change:
- Recruiting 2016-11 -> 2017-09
- last_follow_up_date 2018-08 -> 2018-04
- primary_compl_date 2017-08 -> 2017-10

Now, can we assume they have changed this data in conjunction with the FDA face to face meeting, assuming an October primary read out based on the dropped exclusion criteria?

I hope the other changed (dropped FDA ..) are just changed XML protocol, not working without FDA consent. But if so, the face to face meeting could also have been triggered by the latest changes? Making FDA questioning WTF is going on here?

Puzzled ..