GTC Biotherapeutics (fka GTCB)

[ThomasS]

Dew, did Pharmathene ever submit its' IND to the FDA? Are they circumventing this formal process via US Gov?

(btw, did R&R give you a "heads up" a week or so ago? lol...)

"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. Following the successful completion of the Phase I clinical trial, the government may exercise its option to fund additional development activities beyond the initial $34.7 million, leading to FDA licensure. The contract also provides the Department of Defense with the option to procure an initial 90,000 doses of Protexia®."