Breakthrough designation granting is inevitableIt's pretty obvious that, after Ph. 1b p#5-6 have reached their 2y+ mark of being cancer free back in August 2021 with a single dose, TLT met with the FDA and received guidances about what would be the criterias that would qualify them for the Breakthrough designation. That's why the TLT's corporate presentation was then updated on Feb. 7 2022 (at the time of excellent news on the COVID-19 news from NML's Dr. Kobasa) to include Breakthrough designation application for NMIBC to around Dec. 2022 (projected) and commercial revenues (projected) early 2023 (only Accelerated Approval program can allow for revenues).
Breakthrough Therapy designation is requested by the drug company. If a sponsor has not requested breakthrough therapy designation, FDA may suggest that the sponsor consider submitting a request if: (1) after reviewing submitted data and information (including preliminary clinical evidence), the Agency thinks the drug development program may meet the criteria for Breakthrough Therapy designation and (2) the remaining drug development program can benefit from the designation. Source: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy
April 16, 2018 Theralase® Provides Update on Phase Ib Non-Muscle Invasive Bladder Cancer Clinical Study Patient Five Shows No Clinical Evidence or Presence of NMIBC at 90 Day Cystoscopy Analysis
Patient Six Shows No Clinical Evidence or Presence of NMIBC to Date
... the fifth patient was enrolled and treated in January 2018. At the 90 day cystoscopic assessment, completed in April 2018, no tumour recurrence or presence of disease was detected. This patient has now met Study endpoints showing achievement of the primary, secondary and exploratory endpoints at 90 days post treatment.
The sixth patient’s 90-day cystoscopy analysis will be completed in May 2018 (so treated in MArch 2018) to rule out recurrent NMIBC. To date, the patient has shown no clinical evidence or presence of disease.
The COVID-19 (March 2020+) clearly slowed the monitoring of patients, all cystoscopies being postponed until the crisis slowed down.
MD&A - April 30, 2021:
with patients five and six demonstrating CR with no presence, recurrence or progression of the disease at 18 months post treatment.
MD&A - August 30, 2021:
with patients five and six demonstrating CR with no presence, recurrence or progression of the disease at up to 24 months post treatment.
Breakthrough Therapy designation is requested by the drug company. If a sponsor has not requested breakthrough therapy designation, FDA may suggest that the sponsor consider submitting a request if: (1) after reviewing submitted data and information (including preliminary clinical evidence), the Agency thinks the drug development program may meet the criteria for Breakthrough Therapy designation and (2) the remaining drug development program can benefit from the designation.
Ideally, a Breakthrough Therapy designation request should be received by FDA no later than the end-of-phase-2 meetings if any of the features of the designation are to be obtained. Because the primary intent of Breakthrough Therapy designation is to develop evidence needed to support approval as efficiently as possible, FDA does not anticipate that Breakthrough Therapy designation requests will be made after the submission of an original BLA or NDA or a supplement. FDA will respond to Breakthrough Therapy designation requests within sixty days (60) of receipt of the request.