@bradloncar Welcome! Swedish summer is fantastic and Lund is great. Looking forward to seeing some biotech content from there. Random tip; get at least one Skagen toast.
@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.
Felt that PD projected a deep calm and a different โauraโ than previously - itโs 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. Itโs because theyโll have regulatory news by then and can provide guidance & explanation to the market. With this date anchored investors wonโt speculate or get cold feet in May/June without news but instead simply wait for the investor day.
@wallstlobo Would love data on how control group in SOL-1 performed with SOL-R rescue criteria applied. Would love โtap-out-dataโ, i.e is the BCVA data muted in Ax arm because vision maxed out? Would love other -relevant- subgroup analysis. $OCUL
@wallstlobo Would love data on how control group in SOL-1 performed with SOL-R rescue criteria applied. Would love โtap-out-dataโ, i.e is the BCVA data muted in Ax arm because vision maxed out? Would love other -relevant- subgroup analysis. $OCUL
@Sjfms1Steven That HD is numerically inferior to Eylea 2mg is fine because it has (marginally) longer duration. The issue here is that HD isnโt 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 dosingโฆ
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 doesnโt really matter if HD looks good though as everyone knows its true durability.
@harvey_ramer Yeah itโs a shit product, itโs just patient group is so mild in SOL-R that patients wonโt be rescued to a large extent in any group.
@harvey_ramer I fear Axpaxli wonโt 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.
@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%
@JeremyFalmouth@Sjfms1Steven@Biotech_FC@sububoston@AscendingBio@InvestorLatin One big unknown is redosing, and especially if HD will perform as well after redose 1 as after the first dose? Here ax might have a slight advantage as SOL-1 suggests itโll be 30%+ drier at wk 24. HD enters 2nd phase wetter & without 6 months of recent loading doses to help it.