Cytodyn Inc (CYDY)

[theswordman]

So we only have what Dr Lalezare said (shown in RED) to go on
That a new protocol was submitted for a new indication--from Dr J here:
I'm also excited to announce that CytoDyn submitted a new phase II protocol to the FDA to evaluate the effects of 24 weeks of leronlimab on chronic immune activation and inflammation in cisgender men and transgender women living with HIV. This protocol was submitted in early November alongside the company's response to the partial clinical hold.

So we go to the next step:
A study that uses a "new" aspect of the drug's use (i.e. different indication, dose, population, etc.) usually requires the filing of an Investigational New Drug (IND) Application. --taken from here--https://tracs.unc.edu/index.php/services/regulatory/ind-and-ide-application-support/investigational-new-drugs

When opening an Investigational New Drug (IND) application with FDA, federal regulations give FDA a 30-day window in which to raise any concerns about the application or proposed clinical protocol that would prevent the study from starting, by placing it under clinical hold.--taken from here--https://www.wcgclinical.com/insights/can-a-protocol-get-irb-approval-during-the-30-day-ind-waiting-period/#:~:text=When%20opening%20an%20Investigational%20New,placing%20it%20under%20clinical%20hold.

So in order:
#1--CYDY applied for IND (early NOV)

#2--The 30 day review period for IND

#3--The IND was not approved in a 30 day timeframe--then there is a "clinical hold" (Now, to be clear, CytoDyn was again placed on a new clinical hold for the immune activation study while we incorporate FDA feedback and prepare a revised protocol. I want to stress that this new clinical hold is often a normal part of the FDA review process on newly submitted protocols.)