N-Nitroso desmethyl bedaquiline

Recently USFDA captured hypothetical formation of N-Nitroso Desmethyl Bedaquiline and this NDSRI kept in Category-I.
The treatment duration of Bedaquiline is 24 weeks which is less than 12 months.
If we consider NNK as a Surrogate and combine LTL approach, then AI would be 1330 ng / day.
Is Regulator accepts LTL approach?