Replies to post #7687 on GTC Biotherapeutics (fka GTCB)

[ThomasS]

"ATryn's U.S. approval process is proceeding on a rolling, fast track basis, a method under which FDA permits the manufacturer to submit portions of the filing as they are ready. GTC submitted the preclinical and manufacturing pieces of the BLA and expects to file complete Phase III data mid-year."

---IMO, the pieces submitted to date were of the greatest importance.