Replies to post #257109 on Biotech Values

[DewDiligence]

IIRC a previous wAMD drug which submitted for [FDA] approval ended up getting approved for a single dose. No continued dosing because continued dosing had unacceptable side effects.

You may be thinking of Visudyne, the first drug approved for wet AMD that is now a niche product. The FDA label permits Visudyne redosing only after an evaluation by fluorescein angiography at three months or later. The label also recommends that the initial treatment be for one eye only until safety can be assessed.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021119s034lbl.pdf

[WorstLuck]

the patients who failed Eylea in SOL-1 seemed to be concentrated in those who had not really consolidated into a dried out state)

That's what you would expect from biology. Yes, the rescue free CSFT suggests that as well.

Re 1: Topline on Sol-R will be available months before any PDUFA date and the masked safety through at least the point of submission (which would include the full first redose) would be part of an NDA package, possibly with later updates, but full 56 week topline safety data (2 redoses, not just 1) will be publicly available Q1 2027 (presumed March) per the last statement.

Re 2: The presentation was very sparse. The novelty of the trial makes interpretation difficult, they limited the time to ~ 1 hour (ran over a bit) and did not go into depth on anything. OTOH there will be a lot more information in a week, so I don't know that it is really that much of a problem unless you are trying to make a trading decision based on that limited dataset in minutes/hours instead of waiting a matter of days (shrugs).

[WorstLuck]

Vabysmo, the drug, probably isn't that much better as a drug than Eylea 8mg. Much of the secret sauce of Vabysmo was in the trial protocol - and now in treatment protocol in most local doctors' offices.

Sol-R is still a bit over 12 months to topline but I've done some preliminary work on it. The 8mg Eylea arm is not powered, not part of the stat plan except to be there for masking, and I'm willing to say it's more likely than not that they won't ever disclose the rescues in that arm because it won't be to their benefit. Enough said.