I’m glas this happened. Will the FDA do anything else following this session? Are we in contact with them?
It’s possible, but I wouldn’t consider it that probable. Despite this meeting series being a general one for rare conditions, we did have regulatory staff in attendance (as can be viewed at the end of the summary). However, that doesn’t change the fact we still suffer from very low numbers in the adverse events database (discussed in more detail in the summary) and questions surrounding causality. Future research will hopefully alleviate the latter.
Regardless, it was great for them to be provided with testimonials from patients, with contextual info re: the condition, as opposed to just looking at the words “cognitive impairment” or “erectile dysfunction” in FAERS.
They’ve got our number, so to speak.
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