GTC Biotherapeutics (fka GTCB)

[DewDiligence]

>did PharmAthene ever submit its' IND to the FDA? Are they circumventing this formal process via US Gov?<

After re-reading PharmAthene’s PR from 9/25/06 (#msg-13565694), I can say that the answer to both of your questions is almost certainly No: i.e. PharmAthene has not yet submitted an IND, but they will in due course.

The relevant language from the PR is as follows:

“The initial stage of development, for which $34.7 million has been allocated, includes manufacturing process development, preclinical safety and toxicity testing, submission of an Investigational New Drug (IND) Application with the United States Food and Drug Administration (FDA), and initiation of a Phase I clinical trial.”

Regards, Dew