RE:RE:FTA-BTD-AA....I agree EnriqueSuave and i also like " based on the clinical study data
collected to date " . Maybe the investigators hinted to TLT that results so far are encouraging or , even better , they might share the data with the FDA very soon and then release the news .
Happy Wednesday
enriquesuave wrote: I like the " it was further discussed and agreed ".
skier59 wrote: I was super happy to see all 3 on the table, very positive in my eyes !
In a 3Q2019 conference call with the FDA, it was discussed and agreed between the FDA and the Company, that Theralase would potentially be eligible for Fast Track Approval ("FTA") post receipt of the FDA IND authorization, based on the clinical study data collected to date. It was further discussed and agreed that Theralase would potentially be eligible for Breakthrough Therapy Designation ("BTD") and / or Accelerated Approval ("AA"), if Theralase can demonstrate clinically significant results (high safety profile and high efficacy response), similar to the safety and efficacy results observed in the Phase Ib NMIBC clinical study (high safety profile and 67% CR) at an interim analysis of approximately 20 to 25 patients enrolled and successfully treated."