Biotech Values

[ghmm]

Not sure if anyone here follows United Thereapeutics (sorry gofish I should have mentioned it before today, right :)) but this seems related to the topic of passing on an interim look.

In their medley of things United announced yesterday, they also cancelled the interim analysis of their TRIUMPH study (inhaled treprostinil) they said enrollment picking up was the reason. Given the pick-up in enrollment I estimate waiting till 200 (UTHR thinks about 220 will ultimately be enrolled) rather then if the interim is done at about 150 would be about 3 months. When they tried to get the protocol changed to have an interim at 100 they were told that even if statistically significant 100 patients may not be enough for secondary end-points. I think with among other things the excellent results of the open-label study recently published the likelihood of success are high, and (hopefully) the CEO is being cautious. A small trial and a low P value I think I'd want to be cautious. I don’t think Dr. Rothblatt has been enjoying getting grilled every call about enrollment numbers and the length its taken, and often has said didn’t want to have to do another trial (implied P < .01 1 trial is needed or presumably 2 with < .05).