GTC Biotherapeutics (fka GTCB)

[vinmantoo]

Quantum,

<My only caution is that although the data points they have are good (safety, equivalence etc.,) they are very few in number. I know this is in a very small patient population and larger trials were not commercially feasible.>

I can't rule out an advisory panel. But you have to keep in mind that GTCB worked with the FDA to design the phase III trial and it was decided then how many patients were need for GTCB to generate sufficient data to merit approval. The phase III trial utilized the requisite number of patients and passed with flying colors. This makes the idea that there were too few patients a bit of a red herring. I do agree that an advisory panal still cannot be ruled out given that rATIII will be the first transgenic protein approved. Howver, I must agree with Dew, I would be far more confident of approval if no panel was convened.