Replies to post #193822 on Biotech Values

[DewDiligence]

When granting orphan drug status, what other factors does the FDA consider, besides urgent need?

The addressable market has to be fewer than 200,000 US patients.

Do they normally consider unpublished data that a candidate has collected?

Not as far as I know.

[masterlongevity]

They don't consider any of that. They only consider prevalence