Replies to post #88242 on Cytodyn Inc (CYDY)

[Amatuer17]

On point 1 - I am looking at dramatic results based on California EIND results

On point no 2 - it is Quadrapule blind trial - so the timeline is
- 14 days after last patient enrolled which is 30 Jun - this is when the last blood for last patient will be drawn
- 2/3 days to send the blood sample to Dr BP lab and get the results and send to Amarex
- Amarex enters all the data, does validation of data completeness (not accuracy) and carries database lock (this is a distinct step in blind trials)
- then they carry all data tabulation, analysis to confirm accuracy of data etc and do the unblinding
- this typically takes 2-3 weeks for larger trials
- this is the first time NP and BP will see full set of raw data
- they will carry further analysis to convert into meaningful information and tabulation to announce the topline data

If you add all this timeline, we are looking at actually 20th Jul and beyond

The sub group analysis, all detailed tabulation (that DR BP uses for presentation) will come much later

For interim analysis all these steps are not needed. They will look

- any adverse events - placebo group and Lero
- how many patients survived after 28 days, placebo vs Lero

If the results are OK, they may not even share details of numbers with NP and BP
and will say continue or not
If the results are dramatic, they will tell the numbers to NP and NP has to contact FDA for next steps - maybe ask for discontinuation if trial as the dramatic results may lead to some decision.

The key driver will be - what is dramatic enough to stop trial? They may need to give all other data to support/justify stoppage

This is based on my past experience with various biotech investment but COVID is different.