Replies to post #246268 on Innovation Pharmaceuticals Inc (IPIX)

[Jhawker]

Here is a good link:
https://www.fda.gov/forpatients/approvals/fast/default.htm

[PlentyParanoid]

LR, BTD was intended to speed up the early clinical stages of drug development without changing drug approval requirements. The last step where FDA can and will help a sponsor with BTD is the design of phase 3 trial. After that FDA is back to its usual gatekeeper duty.