I think the granting of the SPA for GENR is great news, but am I the only one who found the SPA to be unusually vague? The number of patients is not specified. The clinical endpoints are not specified. Has anyone ever seen an SPA quite like this one?
An unusually cerebral discussion (by Yahoo standards) has taken place on the GENR board today about the degree to which GENR’s patient enrollment in the phase-3 Evizon trials is behind schedule.
What is indisputable that the second phase-3 Evizon trial is late getting started—it was supposed to begin in mid 2005 (#msg-6798371). The question is whether the delay in starting the second trial signals that enrollment is sluggish in the first one, which opened for business in late June.
Given the expected impact of Lucentis’ clinical results on the inclination of patients to enroll in a placebo-controlled trial of a lesser-known drug (Evizon), I contend that the inference above is a reasonable one.
Under the circumstances, I think the market is apt to interpret GENR’s refusal to give enrollment figures or rough timelines for completing the phase-3 trials as an indication of trouble on the enrollment front. Actually, judging by the stock price, it looks like the market already has taken such an interpretation.
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