Replies to post #251911 on Biotech Values

[WorstLuck]

Yeah, it's really hard to comment on the results without further breakdowns, some of which you provided.

The biggest problem was the size and duration of the trial. The data as presented showed the 400 mg arm as indistinguishable from placebo. That shouldn't be a surprise just given the trial design - any or all of the arms could have looked that way. Nothing about the trial suggested they would be able to achieve and maintain enough CST improvement to be clinically meaningful and, oh by the way, the FDA does not use CST as an endpoint.

That they showed a P value for separation of placebo and 200 mg was extremely disingenuous. There was no valid statistical examination for that data set. And a drop of 30 µm from a baseline of something over 300 µm in twelve weeks means nothing. You are in OCUL if I recall. The P1 they ran in Australia had a small cohort of treatment naive AMD patients drop from 484 baseline to 232 over the same time frame picking up 17 letters BCVA in the process.

So I would guess that if there is a drug there it is slow acting and/or weak. I would guess it would take a 12 month trial to have a chance to show something.