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Re: iwfal post# 252282

Friday, 06/21/2024 11:23:02 AM

Friday, June 21, 2024 11:23:02 AM

Post# of 252390
OCUL

Two of mine would be:



re concern A) your comments reflect the difficulties of gene therapy. The potential AE's you mention (from GT) seem to me far worse than the concerns of being in the Eylea arm of the Sol-1 trial, especially in light of it being a treatment that has waning effect and redose issues. It would take GT solving some combination of durability, AE's, and redosing issues to take market share of concern for a non-GT treatment.

B) is an open Q until they come back from the FDA and have a finalized design. It's definitely something to worry about and slots in as two of my top concerns, after taking into account what they are trying to get done in one trial. It would be easy enough to run a Sol-2 under SPA for approval needs, this is trying to show both non-inferiority and redose while eliminating the need for Sol-2. No small task. OTOH this team really is the team you would want to design that trial. So it's a near term inflection point when they come back with the finalized design - and the implications. Why two of my top concerns? I'll let you figure that out.

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