FDA designation ahead of AUA congress would be amazing AUA congress will be held April 29 - May 1st.
FDA granting us Breakthrough Therapy designation ahead of such major urology congress would give us instant visibility. All big pharmas in the urology field will be on site. It won't go unnoticed.
Imagine if instead of Breakthrough Therapy designation, the FDA decides to directly grant us Accelerated Approval (like Roche and Merck got them) given the holy grail key attributes of our treatment, when compared to what has been approved so far:
- the impressive safety track record of TLD-1433 (QOL - Quality of Life),
- the high complete response (CR%)
- the high durable response (DR%)
- the low number of treatments (1-2 and done)
- the wider accessibility of the drug (non-discrimination among patients (i.e. not scanning for a specific genetic profiles, so making this drug available to a much larger pool of patients, when compared to Keytruda for example))
- the low number of exclusion criterion
- a standalone treatment (unlike ImmunityBio, Keytruda and others)
- a treatment not relying on BCG (unlike ImmunityBio, Keytruda and others)
- a treatment not counter-indicated for immunosuppresed or immuno-deficient patients (unlike Ferring)