Replies to post #107339 on Biotech Values

[jq1234]

why did the fda give them guidance that such a small trial would be acceptable?

Because AMLN/LLY took the shortcut, sought approval via 502(b)(2) route. The benefit of this route is to save time and money, the risk of this route is FDA considers the drug significantly different from referenced drug, thus requests more data. FDA couldn't say you couldn't use this route years ago when there wasn't full data. It's always sponsor's burden to prove ones case with full data.