Replies to post #5440 on GTC Biotherapeutics (fka GTCB)

[DewDiligence]

>Canada: Do they just accept FDA and/or EU data for approval via some mutual recognition process?<

Canada has its own full-fledged review process.

It is not necessary to have Canadian trial sites to get Canadian approval, but it may help in certain instnaces. Leo has a Canadian trial site in the phase-2 DIC study in progress.

[Isotope Feeney]

See; Health Products and Food Branch.
http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/index_e.html

Access to Therapeutic Products: The Regulatory Process in Canada
http://www.hc-sc.gc.ca/ahc-asc/pubs/hpfb-dgpsa/access-therapeutic_acces-therapeutique_e.html