GTC Biotherapeutics (fka GTCB)

[DewDiligence]

>In the manufacturing world, the senior design engineers create a design and usually a prototype. After all the decisions have been made and all the testing has been completed, you could send the part out to any number of fabricators who would then deliver your part per the specs… [For GTC,] I have to assume that the design, the prototype, the testing, and the final production are tightly cemented into a model that is much more complex and unpredictable.<

What makes the drug business different from manufacturing in general is the much higher degree of government regulation at every stage of the process.

>If GTC's counterparts to this process were capable and competitive AND had a lower COGS, then we would certainly have a backlog.<

What’s needed in order for us to see FoB companies lining up for GTC’s services is regulatory authority from Congress to allow the FDA to approve more FoB’s. To date, the only kinds of FoB’s that have been approved are those for simple proteins such as Omnitrope which, for historical reasons, are regulated as though they were small molecules (#msg-11358021).

In short, the FoB game is not even the bottom of the first inning.