TriumphSpitSix wrote: This Novartis example only serves to emphasize Theralase teams' total incompetence.
Novartis' BTD process took
7 months, start to successful finish.
Theralase has been fumbling around with BTD submissions for
over TWO YEARS.
"Fast track" my @ss.
Theralase Releases Q222 Interim Financial Statements
...
In 2020, the FDA granted Theralase
® Fast Track Designation (“”) for Study II. As a Fast Track designee, Theralase
® has access to early and frequent communications with the FDA to discuss Theralase
®’s development plans and ensure the timely collection of clinical data to support the approval process. FTD can also lead to Break Through Designation (“”), Accelerated Approval (“”) and/or Priority Review, if certain criteria are met, which the FDA has previously defined to the Company for BTD to represent a complete clinical dataset on approximately 20 to 25 patients enrolled, treated and assessed, who demonstrate significant safety and efficacy clinical outcomes.
In 2021, Theralase
® completed its first significant milestone of Study II by enrolling and treating 25 patients.
The Company will compile a clinical data report for submission to the FDA in support of the grant of a BTD approval after completion of the 450 day assessment for 25 patients, expected in 4Q2022, subject to the Clinical Study Sites (“”) availability to complete all required assessments.