Replies to post #6931 on Biotech Values

[DewDiligence]

Guilty until proven innocent:

>>The FDA also uses the null hypothesis. As it relates to biotechs, there are two versions of it that go hand in hand: 1) a drug X for a condition Y at a dosage Z is not safe until proven otherwise. 2) a drug X for a condition Y at a dosage Z is not efficacious until proven otherwise.<<

That’s a good post, PGS, but I wonder if it didn’t go over the head of some readers. In case it did, let me try to make it even plainer.

In reviewing a new drug application, the FDA starts with the assumption that the drug is dangerous as hell and does not do anything useful. If you want to get your drug approved, you have to prove that the FDA’s starting assumptions are wrong.

In other words, the FDA operates in the opposite manner as the criminal justice system: the modus operandi is guilty until proven innocent.