GTC Biotherapeutics (fka GTCB)

[go seek]

FDA's insistence on maintaining the exact manufacturing technique... for FOB's

I recall this being mentioned in Canada's recently proposed legislation for FOB's.

In effect you are saying that the FDA would require additional trials for any FOB that did use same manufacturing methodology as the approved drug.

Is it likely this policy will change w/ US FOB legislation?
If not, what would be selling points of GTC's FOBs to overcome this hurdle?








"Ninety percent of this game is half mental." Yogi Berra