Rasmus H

@birgirm80 @moprocto @nalyticsatwork Even if they don’t the period between filing and decision is traditionally where most transactions take place

@moprocto @nalyticsatwork @RazBioTech Acceptance might push shares up?

Important for expectation management ahead of $OCUL investor day in June

@nalyticsatwork Ah okay I am not sure - hope you are right!

@RazBioTech I’m pretty certain that for the 505 b 2 the clock starts as of the nda submission date.

@nalyticsatwork No because the 10 month clock starts ticking 60 days after submission. If they submit in July 2026 the decision likely July 2027.

@RazBioTech PDUFA in May of 2027 most likely if nda acceptance is received in July. Anything earlier than that would be a win.

@JeremyFalmouth Most likely is that the regulatory path is taking shape in a real way. Just me speculating. No idea on timing other than the investor day timing having something to do with it.

@RazBioTech I didn’t expect there to be a q&a this upcoming earnings given the investor day in June. May be some progress to discuss

Felt that PD projected a deep calm and a different “aura” than previously - it’s clear to me something has been unblocked behind the scenes. Either on the regulatory side or a progressing courting process. Quite confident holding $OCUL

@AscendingBio None of those. It’s because they’ll have regulatory news by then and can provide guidance & explanation to the market. With this date anchored investors won’t speculate or get cold feet in May/June without news but instead simply wait for the investor day.

$OCUL Anyone care to speculate about why they have announced Investor Day on June 17, 2026?

@Biotech_FC Good question, I actually don’t know, just sort of assumed it’d be made available and that it was for safety

@RazBioTech I thought patients that were re-dosed in both the Axpaxli and Eylea arm will have their data masked after redosing… or maybe I am wrong! $OCUL

$OCUL redosing data from SOL-1 is also not out of question though likely too early. Remember all patients got a second Axpaxli dose at 52 weeks…

$OCUL $EYPT $KOD investor.regeneron.com/news-releases/…

@wallstlobo Would love data on how control group in SOL-1 performed with SOL-R rescue criteria applied. Would love “tap-out-data”, i.e is the BCVA data muted in Ax arm because vision maxed out? Would love other -relevant- subgroup analysis. $OCUL

$OCUL-so now Dugel wants to present "additional data" on SOL 1 at a conf on April 11. What data does he have that he hasn't diclosed at 3 conferences last month? Seems like he's dragging this out for what purpose I don't know.

@Sjfms1Steven That HD is numerically inferior to Eylea 2mg is fine because it has (marginally) longer duration. The issue here is that HD isn’t dosed according to label in SOL-R, but at 6 months - the exact same cadence as Axpaxli. So if RFR Ax vs HD is the same, at the same 6m dosing…

Eylea showed better than HD Eylea in P3. But HD met the non-inferiority requirements. Given the inclusion requirements of SOL-R, I would expect the same to be true. Where Axpaxli ends up compared to the two, doesn’t much matter as long as it’s non-inferior. Real world is likely to be somewhere in between. Remember, real world shows most HD and Vabysmo being ~ 12 wks. SOL-1 probably gives the greatest insight in capability of Axpaxli with respect to controlling disease…. Which is why it is called a superiority test.

My take; Eylea HD will do well in $OCUL SOL-R even when stretched to 24 weeks. Reason: inclusion criteria. Patients are stable. In this mild group the HD-arm will do better than in market. Study will hit, look optically/commercially questionable but Ax will still own the market.

@harvey_ramer We can call them well controlled. They are recruited to be as easy as possible to maintain. On top of that, rescue criteria is 5 ltrs AND 75um. More liberal than the Ph3 HD trials. Ultimately it doesn’t really matter if HD looks good though as everyone knows its true durability.

@RazBioTech Are we sure they are mild or just well controlled, and screened for stability under vegf therapy?

@harvey_ramer Yeah it’s a shit product, it’s just patient group is so mild in SOL-R that patients won’t be rescued to a large extent in any group.

@RazBioTech The half life is a bitch once you get outside of carefully crafted clinical trials. retinalphysician.com/issues/2025/ma…

@harvey_ramer I fear Axpaxli won’t have an edge on rescue free rate against HD in this population at 24 weeks. I worry that will look very bad optically. I am fairly confident Axpaxli meets non-inferiority against 2mg on protocol, so study will succeed.

@RazBioTech I should have clarified. Marginal improvement in durability. I very much doubt the HD arm will have a stat sig improvement in bcva or cst over 2mg at any timepoint after randomization. I also expect it will show inferiority to both 2mg and axpaxli at 4-6 months and 10-12 months.

@harvey_ramer Agree 100% that HD will only show marginal improvement vs 2mg - unfortunately marginal improvement is all it takes, as the delta between 2mg and Axpaxli groups at 24 weeks was just 8%

@RazBioTech I strongly disagree. Respectfully. This is a different patient group than sol-1. HD will likely show only a few weeks over 2mg.

Thought about this in $OCUL SOL-R study, any thoughts?

@Mikeptyg @JeremyFalmouth @TripESU89 Screenshot from FDA’s website.

@JeremyFalmouth @TripESU89 How ? Show me the proof ?

It’s kind of ironic that $OCUL investors don’t know they were the ones that were mislead by the fake Duravyu safety data . The “Dream Team” wants to downplay $EYPT as a competitor by presenting a false narrative on Duravyu safety data. Pathetic move by $OCUL .

@JeremyFalmouth @Mikeptyg @TripESU89 I’ll do it

@Mikeptyg @TripESU89 Well there is the number “3” listed in the endoopthalmitis row for the 3mg treatment eyes…I’m not going back to the clinical trials site to snip the image for you.