Biotech Values

[masterlongevity]

Yes that is true. the fda does not require you to show efficacy in phase 2 to move to phase 3. you are not even required to meet with them. its dumb not to, but you can just send them your phase 3 protocol and wait 30 days to start. if you're not put on clinical hold, you can start a phase 3 without any communication whatsoever. on the other hand, EMEA does require sufficient risk benefit in the ph 2 to allow a drug to move to phase 3