GTC Biotherapeutics (fka GTCB)

[DewDiligence]

>…FDA insistence that the protein sold must be made, eg by cell culture, by the same method of the protein that was created for the trials.<

This is an important point—companies that want to employ GTC’s production platform have to sign on early in the development timeline, as Merrimack did with MM-093.

>If it is made by a different technique, eg transgenics the FDA would consider it a different drug which would have to go thru a completely new set of trials.<

I would agree if you omitted the word completely. The premise of FoB’s is that characterization and in vitro analysis will enable some reduction in clinical testing, the amount of reduction being determined on a case by case basis.