GTC Biotherapeutics (fka GTCB)

[jessellivermore]

What hurt GTCB is the idea the FDA might never approve transgenics.........

Vin,, I know you have been a good soldier in the goat army, but IMO your statement is incorrect. Perhaps this sentiment might have some validity prior to the EMEA decision, but I can not remember a single example where FDA reps have sugested they were going to have a problem with mamalian transgenics. Furthermore we are now one week post FDA and no bites.

The reasons BP has not come forward with partnership deals has more to do with the details of how biotherapeutics are introduced to the long pathway through the FDA regulatory process, ie by small biotechs using cell culture which is faster and initially (at introduction) cheaper. By the time BP enters the process the drug is already designated a "cell culture drug" and FDA rules do not permit BP to "switch" to transgenics unless they are willing to start the pre clinical trials from the begining. It also does not help that BP is not particularly interested in production cost reduction.

It is possible a BP might be interested in GTC's NPPP for plasma proteins. A smart BP could see big profits in 4-6years.

JL