RE:Breakthrough Therapy Designation
nemo3 wrote: From TLT's last press release, TLT needs to enroll and treat 20 to 25 patients for consideration for BTD. At the time of the press release, 12 patients had been treated. Their second treatments may have been sidelined by COVID-19. One can hope that if there are no further shutdowns in the hospital settings that TLT will have close to 100 patients treated by the end of 2020.
I am not clear on whether these first 20 to 25 patients will need to meet a complete response at one year or would 3 months or 6 months be sufficient for consideration for BTD? Anyone know?
I interpret their comments to mean a BTD request would be warranted once a total of ~25 patients had received their first treatment. Interim data would therefore include CRs at various stages (3 mo, 6 mo, 12 mo...). BTDs have certainly been granted for less in the past. The company also stated....
"As of April 27, 2020, 12 patients have been treated representing approximately 50% of the interim milestone to submit an analysis to the FDA in support of a BTD."