Cytodyn Inc (CYDY)

[Cindylou822]

Clinical databases are slightly different. A better comparison may be Chinese dialects. You can communicate well enough in person, but when you try to write things down, it may not translate because the symbol you chose for one dialect isn't discernable by someone using a different dialect and you are left with no idea of what symbol you would choose. You know something is being said, but you don't know what. All of that gets left in translation. You don't even know it's a problem unless someone tells you it is. That's normally a CRA or data manager and it shows up through the query process. This is standard practice in the industry and, most likely, a completely foreign concept to FDA reviewers who take a hands off approach to database auditing and use forms and reports for their findings. If they had added a query process, it could have gone back to data management and a worker bee somewhere would have figured out the problem - most likely because their metrics depended on it and no one wants to go into their annual review with bad metrics.
My suggestion would be to ask the FDA to print off an electronic copy of the CRFs (or whatever they call the visual aspect of the database), send it to the company after it's been confirmed as received and uploaded and wait for a validation before moving forward with the formal review. It would add a step, but alleviate frustration and wasted time on the part of the FDA.