Biotech Values

[iwfal]

XOMA -

it [delay of NIU trials due to slow set up of ex-US sites] puts in question whether the EYEGUARD-A and EYEGUARD-C studies will ever enroll enough patients to have sufficient statistical power to demonstrate efficacy in NIU.

1) I've personally had experience with the schedule impediments associated with setting up ex-US sites (albeit not in the area of clinical trial setup). It does eventually happen - just takes longer and you end up having to write off a few countries as just too hard. Last comment is that they are right to avoid making further predicts because, by the very nature of most country specific negotiations, 'surprises' happen. But if you really focus, make personal appearances, ... things can happen reasonably quickly.

2) In terms of management being overly optimistic about their schedules, this looks like it is only mild by comparison to the worst I've ever seen (Momenta's claims about bio-generics were laughable and unfathomable given their experience to date on small molecule generics).