Replies to post #245701 on Biotech Values

[dewophile]

They are going to be watching for GBS very carefully in the real world regardless of any post marketing study. It’s the only practical approach given the rarity of the condition.
This same approach over time led to a warning for shingrix as an excess of 3 GBS cases per million doses was found. So postmerketing surveillance today seems to be pretty good IMO

[jbog]

Pharma has poor track record on post-marketing studies and timely reporting of those results as far as I recall

The FDA has changed the rules. In Practice they will not give an conditional approval unless a conformity trial has for the most part started. It's slowing the whole process down.