Applying for Breakthrough seems very close now It's in the order of things that now that they met with MSAB (*1) after the AUA congress to have a final guidance and final review, that the work with a biostatistician and the regulatory organization is close to completion as in the April 23, 2023 MD&A, they were already working with them to compile a clinical report to apply for FDA Breakthrough.
So submitting the report to the FDA is probably very close, now that data has been revised.
*1:
In recent discussions with the Medical and Scientific Advisory Board ("MSAB") for Study II, the MSAB advised the Company to review the FDA Guidance to Industry1 on how to best classify Indeterminate Response ("IR") patients (patients assessed with negative cystoscopy and positive urine cytology), where the source of the positive urine cytology has not been determined.