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DewDiligence

02/04/08 7:38 PM

#7567 RE: vinmantoo #7566

>…we can assume that for the historical plasmid derived ATIII trials, there must have been at least 1 patient with clinical DVT.<

We don’t actually know this because we don’t know the pre-specified non-inferiority delta. Please see #msg-25866013 for the relevant calculations. Regards, Dew

MTB

02/04/08 9:10 PM

#7577 RE: vinmantoo #7566

Hi All,

GTCB's Phase III trial was simply replacing a hereditarily deficit protein of the clotting cascade -- which had long ago been proven to be effective when the ATIII had been harvested from serum -- and proving it no worse. Even without knowing the very positive results of the European trial (which we did), everyone who had any confidence that the goats were actually producing and patients were actually receiving rATIII (and wasn't a physicist) had VERY good reason to have expected today's news. Congrats and the pps won't suffer never the less.

What will be interesting and MUCH less assured (but with MUCH larger potential for upside effect on the pps) will be the Ph. II results from LEO in the acquired indication.

Will be looking for good movement with the partnership announcement next.

Best,
MTB