Replies to post #17114 on Cytodyn Inc (CYDY)

[Grip it and Sip It]

Can you decipher this data for some of us?

Thanks!

Grip

[finesand]

Re: Changes to NCT02483078, FDA Meetings & Delays

.. meaning this could either mean next month primary data readout and 'soon' publishing some results with the BLA application post FDA meeting - or - the FDA is not happy with the trial changes.

Yes, I would love to read your comments on my previous post.
In case of the former, this would be very positive of course.

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 ..