Did it cost the same amount to approve Silenor for insomnia as it would cost to approve a really novel drug much better at combating insomnia than any existing one?
The FDA wants proof that drugs have a statistical significant effect. The stronger the effect of your drug happens to be the less people you need in your phase III trials.
The FDA wants proof that drugs have a statistical significant effect. The stronger the effect of your drug happens to be the less people you need in your phase III trials.