Biotech Values

[DewDiligence]

Re: I-vation + Lucentis?

>Should they wait until the fall, or should they assume a favorable outcome in the DME trial and submit an application to get the ball rolling for AMD asap? In hindsight, combo-AMD with Lucentis looks like a better indication to pursue initially.<

Given that Lucentis isn’t yet available commercially, SRDX will not lose much time by waiting until they have results from the phase-1 I-vation trial in DME this fall.

>if I remember correctly, DME treatments have a shorter regulatory approval process than AMD treatments. Thus, if I-vation pans out and recieves approval for DME down the road, it could be used off-label for AMD combo therapy with Lucentis until an approved combo-treatment becomes available (if it does).<

It’s the other way around: DME progresses more slowly than AMD and hence the FDA has required three years of data to submit an application in DME vs one or two years to submit an application in AMD.