Biotech Values

[DewDiligence]

>>Do you suspect that if in fact the results from lower doses are not as good, that means Squalamine's overall affectiveness may be not as great? <<

No, that’s not the point. It’s quite plausible that Squalamine could be efficacious in AMD at 40mg but not at 10-20mg. Large, controlled studies for a longer duration (the “209” phase-2 trial and the eventual phase-3 trials) are needed, but the chance of demonstrating adequate efficacy at 40mg appears to be quite good.

Nevertheless, GENR appears to be in an uncomfortable predicament. On the one hand, today’s PR takes the bloom off the rose about the 10mg data set reported last October being “positive.” (As I noted at the time, it was anything but.) Moreover, since GENR has not disclosed the 20mg data, it is reasonable to infer that the 20mg data are not a whole lot better than the 10mg data.

On the other hand, there may be reluctance on the part of the post-Vioxx FDA to accept a dose as high as 40mg for an anti-angiogenic drug given systemically over an extended period of time, perhaps as long as two or three years.

It may all work out for GENR, but the margin for error has shrunk.