It feels hasty (my a, b, c above) but is also an UNBELIEVABLE power move. It’s gutsy, aggressive and high stakes. Go to market in -26 vs filing mid -27! To be a fly on the wall where these decisions are made!

They’ve spent months polishing their strategy and then within a matter of a week scrap their entire regulatory strategy? Haven’t yet digested this, but ultimately might be the right move: to immediately respond to changing conditions is actually strategic

Three other issues are a) what about data supporting re-dosing? This is critical for label and commercialisation. b) what about the safety req’s that they now don’t have n for? c) will clinicians prescribe this without non-inferiority trial having gone through FDA scrutiny?

$OCUL I haven’t decided if I like this. Market hates uncertainty and there must be a higher risk of CRL with this approach vs waiting. I understand downside risk is capped by that potential CRL being sort of instantly re-fileable (that time together with SOL-R data)

Given yesterday’s update, assuming clinical success, Vabysmo should be the absolute floor on what commercial uptake to expect. Takeout value is 4x peak. $OCUL won’t change hands for less than $12b.

$OCUL post dilution per share

$idya down 4% at open, makes zero sense but feel that those with patience to hold through q4 will be rewarded

Handy $OCUL guide for all dreamers out there $XBI

$OCUL I keep thinking about how $KOD reached $6bb in mkt cap before they card flipped (failed) trial results for #wetamd. Look at you $OCUL at $2.1bb and 5 months-ish to go.

Hmm not ideal. I do think $OCUL has a better asset, a better team, and judging by the relative marketcap so does the market.

$4.4b annualised - if $OCUL proves itself with Axpaxli this is the benchmark. Not out of question for Axpaxli to change hands for $15b. Stars would need to align - but it’s within the realm of possibilities.

Posted this more than a year ago $OCUL

Very interesting regulatory take on $OCUL, $EYPT & $CLSD and their wAMD Phase 3 strategies

Has a huge position in $MIST. Knew it was a binary, knew it was high risk. Holding on to all of it at a massive unrealised loss. It will get approved. Hopefully in 12 months. Issue (obviously) is financing overhang, and with a $40m mcap there’s no other way than brutal dilution..

$MIST for the bulls. Launch timeline expectation, is quicker than I thought. But I wanted to add, FDA changed the goalposts (after) the NDA was submitted and approved. Milestone may get quicker / kinder treatment because of this. It should in theory be fine. IMO

$MIST this will clearly get to market, question is now what sort of time this review cycle will take. Benchmarks anyone?

$MIST CRL

Made an absurdly intricate spreadsheet to answer question of: "why did this credible person pick this company for the @pawcio2009 #Biopick2025 contest?" Catalysts for 53 co's from prev winners / "100% club" Shared this with smaller group here already https://t.co/H881MkO7FI

$CGON and $TARA (long) both have conference calls on dec 5th

BREAKING: Trump picks Johns Hopkins surgeon Makary to run FDA https://t.co/p2YVKve4AO via @statnews