RE: My opinionBig leap from healthy normals into patients from a regulators perspective. Don't forget the pressure they are under. Perfectly good arguments on why you should fast track a bunch of different drugs to treat a bunch of different indications but they don't...
Why don't they? Because of experiences like the one with
TGN1412 which was developed by
TeGenero.
https://en.wikipedia.org/wiki/TGN1412
Patients die and people try to hang the regulators out to dry. And so they take a slow and steady approach unless the political pressure is enourmous. The only time that worked was with Act-Up when they pushed faster dissemination of the anti-HIV retrovirals and when they pushed to get Herceptin out to cancer patients. I do not see such a massive mobilization happening for this short term outbreak despite how heartbreaking it may be to watch kids die.
Even if TLN is discussing some type of study in Europe (which I doubt since they don't have any $$$ to run it), I suspect that by the time they get regulatory buy in it would be end of year. By that time the window has passed.
Once they get data from this study in South America things could change and move faster, but I suspect the best we can hope for is an outbreak in South America so that they can wrap up a trial fast and get that data.
PK