Replies to post #189139 on Biotech Values

[bxjwn9ru]

Many folks here say a drug doesn't have to show any efficacy in order to proceed to a phase III trial; just exhibit safety.

A lot of people benefit financially from the running of Phase III trials so it would not surprise me if the above is correct.

[biomaven0]

If you are testing a drug with little in the way of a safety signal in combination with an approved therapy, then I very much doubt the FDA would ever try to second-guess you on efficacy in deciding on a Phase III. So in that context the FDA OK to proceed to a Phase III has little (if any) significance.

If the proposed trial is one-up against an approved therapy, then I could see the FDA showing more interest in whether there were plausible signs of efficacy.

Peter