Biotech Values

[jq1234]

When it was noted that there were a higher number of deaths in the Neudexta arm, I thought for sure the drug would be rejected.

The death inbalance was explainable because ALS patients in placebo arm had significantly lower mean time to ALS diagnosis. ALS patients have fairly preditable life span after diagnosis. FDA was cautious by approving only 20/10mg dosage.

This just goes to show the unpredictability of FDA decisions

I think people think FDA is a monolithic group. If you compare drug approval across different divisions, you might draw unpreditable conclusion. However, if you look at drug approval by division, you might conclude they are fairly consistent.

AMLN, ARNA, VVUS, BIOD (I assume CRL on BIOD) all came from same division, AVNR, ALKS came from same division. It's a mistake to compare across different disease and patient population. Endocrinologic and Metabolic division had many problematic approvals in the past, so it is not surprising it seems they are tougher than before, and I think they should.

The most unpreditable part of approval/delay to me is preclinical data issues and manufacture issues because these are less disclosed by companies to investors.