AAVL
Another possibility re retinal thickness increasing is that the treatment isn't fully working and the condition is worsening, even if VA doesn't correlate with that deterioration.
What makes you think its a safety issue, and to be clear, you're saying its a problem with the standard subretinal injection, not the vector/promoter is causing the increase, or bit or both, or something else? If subretinal problem, care to expand on how you come to that conclusion, as AAVL have said no issues with safety. And how does that correlate with any other programs at AGTC/ONCE that are subretinal?
The size increase is pretty small, certainty compared to the Ph1 its a big change in direction, but then the starting point is very different in the Ph2a with subjects having milder disease. Likely we won't get to the bottom of this until the data is fully published later this year, and/or they discover issues with the OTC data from the image reading center.
AVA-201 would be the do over, if subretinal isn't viable, which is a intravitreal injection. Yes its pre-clinical so major delay, and still unproven that intravitreal administration can reach the required parts of the retina.
The Ph2b is that next trial, or you expect another one on top of Ph2b for some reason? Agree on the cost, difficult to know the size and cost, nothing communicated so far.
Care to explain why you think 7.5 letter improvement on top of previous improvements from SOC is needed?
Agree on the rescue injection figures. Too many.