Biotech Values

[DewDiligence]

Re: ALTH:

>> The short of it is that, although RSR-13 has no toxicity and could therefore be given a conditional pass, the committee did not want to do so because it would have meant that further trials would be compromised since no doctor could ethically administer a placebo in a further trial. <<

I think they will have some trouble enrolling patients in the new breast->brain trial even after the ODAC rejection because it’s an open-label trial.

My take on the rejection is different (and simpler): I think ODAC, with pressure from the FDA itself, does not want to open the floodgates to all sorts of wacky ex post facto analyses. Their panel members’ hearts may have leaned toward approval, but their heads said “Hold the line or this will spiral out of control.”

>> Makes you wonder if you could use the same trial to run two or more NDA's - one for all brain cancers, one for breast->brain, one for lung->brain, etc. <<

If the bifurcation is done retrospectively, it’s the same problem all over again, so the short answer is No.