It's all in RDGL updates. 1st draft IDE application was reviewed at 1st meeting in Nov. 2021. It took RDGL over a year to respond with the 2nd draft, from which the most recent questions arose and remain unresolved after 4th meeting. Likewise, it's very clear from updates MK blamed FDA for, resisted and foot dragged against the needed containment imaging and dosimetry data, which FDA has yet to receive and review.
Again, hard to imagine coming to FDA without containment imaging and dosimetry data, and being surprised those are needed in an IDE application, but that's exactly what happened. Years lost as a result, aka gross incompetence.
Still chance Radiogel gets to human trials this year, but that's less likely by the day. It is what it is.
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