FDA Breakthrough application is still aliveConsidering:
- that BCG-unresponsive patients with high-grade CIS are clearly at risk and are left with little options other than cystectomy that will impact their quality of life, on top of having a risky 6-7 hours surgery that can be life-threatening,
- and considering that other biotechs/pharmas have been granted FDA Breakthrough designation,
- and that TLT management mentioned that they were working with biostatistician and regulatory body for Breakthrough Therapy application
- and that Research Capital Dr. Uddin also mentioned about imminent FDA Breakthough application
- and that Breakthough application would accelerate the review of our data for potentially AA program
- and that Accelerated Approval would allow TLT to claim revenues much earlier
- and that the ImmunityBio delay regarding its manufacturing issues raised by the FDA is an amazing opportunity for TLT to favor the fastest path to commercialization and to shift competition
I doubt that TLT will skip the application of Breakthrough Therapy.
Dec. 2019 -
ImmunityBio Granted FDA Breakthrough Therapy Designation for N-803 IL-15 Superagonist in Non-Muscle Invasive Bladder Cancer - ImmunityBio