Cytodyn Inc (CYDY)

[Hold10]

trial timelines please learn. ADD IT UP.
you literally only know the glossy edges of leronlimab science. you know nothing at all about therapeutic development timelines. i have spent hundreds of hours studying therapeutic development, including timelines. no one... no one anywhere ever finishes a robust p2 (a p2 that will allow yo to move on to p3) in less than 2 years for hiv, oncology, NASH or anything cytodyn has ever considered or will ever consider. go look at a couple dozen completed trials. 2.5 is FAST.

when i say 2.5 years p2 and 3.5 years p3... that is AGGRESSIVE. can easily be 5 years or even more for a robust p3.
every trial involves several time consuming elements. each of them takes several months. some elements take 1 or more years.

1. protocol design and approval. the design takes months. the approval can also take months.

2. site setup. this takes months, even as long as 6 months or more. each site has its own internal procedures. its not "oh we think it'll be swell to work with you, where do we sign?". its a process involving departments and meetings and resource allocation and tons of paperwork and signoffs and more.

3. enrollment. this can take multiple years for some p3 trials. always take many months, even up to a year or even more, for some p2 trials.

4. dosing and observation. bare minimum 6 months for a robust p2 (a p2 that will be adequate to then move on to a p3), but usually longer than 6 months for the full results set, all endpoints. 12 months always preferable for leronlimab indications. for p3 it can be 24 months or longer. they need to report on DURABILITY vs disease progression.

5. dataset lock. this is always more time consuming than anyone expects. several months. for large trials, like a NASH p3, it could even take a year (that's a bit long but it happens), depending on the trial design.

6. top line analysis and presentation. again... several to many months, can even stretch for a year or even more for some large complex trials.