@UpsideDownUnderExcept that would be a LIE. I may err, but I wont LIE! Try it!
The FDA doesn’t disallow trial methodologies. Its role is to assess, approve, or license treatments - not dictate specific designs. It sets minimum requirements, and companies are free to submit any trial structure they believe meets the standard.
In fact, head-to-head trials are common in therapeutics, but many companies avoid them strategically - due to cost, risk of unfavorable comparisons, or timing. It’s usually a corporate decision, not an FDA constraint.
Telix got turned down last week although they had previously met and agreed with the FDA on what to submit. They were now told they needed to provide more data - Telix say they already have the data and can also get some from other researchers. How come Telix have other data?
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