Is that from the Morgans' note?
Whatever the case, there are a couple of reasons this is unlikely to be a huge issue:
- The FDA will have seen practicalities like this before with injectables that have been approved (eg, with enoxaparin). It isn't a show-stopper.
- The trial will be measuring a raft of objective data points (eg relating to MRI) that won't be affected by issues with blinding.
Long story short - trial protocols are there to try and mitigate most of the risks to validity, but none are perfect at doing so.
research reports and media, page-1548
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