Cytodyn Inc (CYDY)

[Cindylou822]

I saw a post on Yahoo that we got the database from Amarex right away and the bond is only needed for the TMF and access to the site for an audit. The on site audit would be for the TMF. That's normally audited in preparation for an FDA audit for drug approval. It still needs to be maintained by Amarex because they'd have to allow FDA to audit it and would get hit with findings if it's not maintained properly. The TMF is basically the study documents, copies of documents maintained at each site (investigator site file) and the CRA trip reports and confirmation and follow up letters. The CRO is responsible for those.

As long as Cytodyn has access to the data, the rest can actually wait unless they need CRA documents to show that the CRO didn't follow their SOPs. The ISF can give you an idea about that based on confirmation and follow up letters.

As long as Cytodyn has people who understand clinical operations and they have their data, they could wait to find out how much they actually owe.