Rajiva35 : Generex!
Generex Biotechnology Corp. (GNBT) said it clarified the development path and timetable for its Antigen Express unit's bird-flu vaccine after meeting with regulators, clearing the way for the company to file an investigational new drug application ahead of clinical trials. In a press release Monday, Generex, a Toronto pharmaceutical company, said Antigen Express representatives had a "positive" pre-investigational new drug application meeting with regulators from the FDA.
The drug is a vaccine designed to protect against the H5N1 strain of avian influenza. The meeting was requested by Antigen Express, which requires a new drug application so the company can test the drug on humans.