read,
There is also variation with cell culture from batch to batch. The issue isn't whether there will be small variations, but whether it matters. In essence, rATIII is a FOB for plasma purified ATIII. The fact that the FDA approved rATIII on the first try indicates it isn't as big of a concern as you seem to think. It isn't as if GTCB will be purify separate batches from each goat, rather they will have several goats producing and then pool the milk prior to purification. I think that you are missing one major point about cost. It includes the ability to scale up, and that is where GTCB has a major advantage over cell culture.
As far as the INSM deal, don't you think it provides at least a small positive for GTCB, given that it is in the realm of a big pharma getting into biologicals?
Are you going to weigh in on GTCB suing LEO? The way I see it is that LEO has been causing delays because they don't want to pay GTCB for breach of contract and they figured that by delaying they could get GTCB to give in and relinquish any penalty payments to free up rATIII. Now that GTCB has FINALLY sued, they should be able to get rATIII transferred to another company before resolving the issue of LEO paying a penalty since both partners want to end the relationship. I do agree with go seek that GTCB should have sued from the beginning and the fact they didn't once again speaks to poor management.
I expect that GTCB should be able to get several million in up front cash from a new partner because rATIII has already been approved in both the US and Europe. Both the LEO and Ovation partnerships were made prio to any approvals. In addition, pricing terms have been negotiated in many European countries and the data exists to have the market expanded in Europe to include pregnant HD women. This means the new partner should be able to rapidly generate sales in Europe. If I let myself fantasize a bit, GTCB will also get a loan from the new partner so that they can pay off the LFB loan prior to June 1st.
