GTC Biotherapeutics (fka GTCB)

[croumagnon]

"There is no SPA."

I suppose that can be good or bad depending on the results!

If the results are superb, say for instance 0 DVTs for ATryn while the historical cases of Plasma derived AT had a 4% occurence of DVTs, then it does not really matter whether or not there was an SPA, although most would feel more confortable knowing that there was a contractual obligation from the FDA to approve (although the FDA is free to break that contractual agreement!)... If the results are horrible, then again it does not matter as ATryn would be failed in either case...

It is when the results are borderline that an SPA could matter. For instance if the results are just slightly as good or better than what an SPA requirement would have been, then an SPA would bode well for approval while a lack of an SPA would give us pause as to what the FDA may do. However, if the results are slightly inferior to such an SPA agreement, then not having an SPA may bode better for the chance of approval because the hard nosed statisticians at the FDA usually like to stick to the number previously agreed upon. Without an SPA, there is no such agreement so anything could happen...