Hi Everyone, I am long time reader of this board but just created my account to clarify some of the technicalities regarding the unblinding process. I am statistical programmer, worked on numerous topline reports and was part of 3 successful BLAs in my short career of 10 years.
01/13 is the last patient last visit day which is not the same as unblinding. As Rockleo pointed out the sites will have 24hrs to enter the data in to the EDC system. Data monitoring and Data cleaning will be performed and queriers will be raised and the sites will have to respond to those queries. There is vendor data to be finalized as well. The safety labs, cytokine panels etc all come from the vendors. Each and every data point has to be reconciled and the database has to be locked. Pandemic or No pandemic the FDA is very strict about Data Integrity. If there are any mistakes during this process, the database has to be unlocked, corrected and locked. Trust me nobody wants to go through that.
Once the database is unlocked, unblinding will be authorized and statistical analysis is done. There are multiple steps in this process. The raw data from the EDC and vendors need to be standardized into SDTM and ADaM formats for analysis. The FDA only accepts SDTM and ADaM datasets and every step has to be validated. The programming to do this should already be in place and if Amarex is competent the whole process should not take more than a couple of days. Usually the sponsor which in this case Cytodyn has a dedicated team working on this producing the Topline report.
In short if AMAREX is on top of everything, we should be able to hear something sometime by mid to end of next week which is my most optimistic estimate. If they are bit sloppy it will add an additional week or two.
The FDA knows this clearly and it might be the reason for the authorization of Open label cohort.
Respect for all the senior members of this board. Rockleo, Black-ops and many others.
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