Here it is again...a quote today from the very same subscription service (Jack Bass team/Apprentice Millionaire) that previously claimed that unless cures were obtained in the PII NTM trial, fast track FDA approval was unlikely. DHW posted the previous claim over and over on this MB, but doesn't seem to support the current opinion and will work to remove it from this MB.
" We see a clear, and likely abbreviated path to approval strongly
supported by culture conversion and QoL data. We think six-month
extension culture conversion, conversion over time, and QoL data to
be presented May 20th at ATS (San Diego) will support a subpart H
filing, a positive AdComm and conditional approval, given what we
see as strong clinically meaningful data in an unmet need."