Biotech Values

[jq1234]

It is a voluntary reporting system, not mandatory like in controlled setting of clinical trials. In the long run, with larger database, it could give some safety signal, but not for short time frame like this unless it is something like severe allergic reaction like Omontys. What I like to see is AE reports from CP patients only.

By the way, this applies to any other short term survey as well. Neither provide better picture than FDA safety review document at this point.