I have got no idea how much the trial would cost to run, pure...

I have got no idea how much the trial would cost to run, pure guess its in that range but maybe more than $20M for several countries, hundreds of participants, many regulatory agencies, and in-field staff - over maybe year(s) is going to be costly. TAK-003 from Takeda for dengue enrolled over 20,000 people! We would need a massive partner to help undertake something this big if FDA pushes this.

I've been looking around for other p3 trial costs in dengue to see what if anything is published. The only data I find is research on is the cost benefit to a drug, good news - it is very cost beneficial to have a treatment lol

Something we have on our side is, its a pill / gel capsule so easy to administer. Sanofi is discontinuing the only FDA approved Dengvaxia in 2026 because of low global demand. LINK. Also, only people who test positive should take this vaccine, so - its not really a hit.

And, Qdenga the other approved Dengue drug requires a two-dose administration, three months apart and is only approved in the EU. As well, Takeda withdrew the US application to the FDA of TAK-003 in 2023...citing the FDA asked for additional data not captured in the Phase 3 trial. Imagining needing to run another 20,000 person trial.

If ISLA-101 comes through, I see its going to disrupt things both because Sanofi is stopping the only FDA approved drug, and Qdenga (TAK-003) isn't looking like its coming to the FDA markets soon. On top of that, add ISLA is only a gel capsule and maybe both a therapeutic and a prophylatic - its application is going to be very broad, and easy to uptake.

I guess our timelines are going to be, results from 2b, detailed results, book in FDA meeting to get direction on P3 design - maybe some consultative advice can guide this, then begin planning it whilst looking for a partner maybe. Not sure, but the sky is blue at the moment