I'm not sure if a drug can be approved without filing for an NDA with BTD application but I know for a fact that BTD does not guarantee approval without an NDA. ACAD Nuplazid got BTD status and they are still in the process of filing their NDA scheduled soon (hopefully). The 6 months approval time you are talking about is actually separate from the BTD. I know for ACAD, the BTD just allowed them to stay in communication with the FDA to help them through the process of filing for an NDA to ensure a better position for approval. After submitting the NDA, they will wait to see if we get priority review designation within the first 2 months of filing. Priority Review means they will have an answer whether or not the drug is approved within 6 months as opposed to the standard 1 year time frame. This has been explained on the ACAD conference calls numerous times as I guess the investment community are always confused about the FDA designations.