Accelerated ApprovalAccording to a page on their website the FDA does not set the bar very high for accelerated approval:
"...instead of having to wait to learn if a drug actually extends survival for cancer patients, the FDA may approve a drug based on evidence that the drug shrinks tumors, because tumor shrinkage is considered reasonably likely to predict a real clinical benefit." TLD1433 pdt does not just shrink tumours - it destroys them and completely eradicates the cancer of NMIBC patients to a greater extent than currently approved treatments. In other words,
TLD1433 pdt has not just provided evidence that it is
reasonably likely to provide a real clinical benefit, it has provided evidence of
a real clinical benefit itself (a durable complete response)
in one third of the patients 12 months after their first treatment. And this has happened almost one third of the way through the trial (31 out of 100 patients).
The FDA on clinical benefits:
"A positive therapeutic effect that is clinically meaningful in the context of a given disease is known as “clinical benefit”. Is there any doubt about whether or not TLD1433 pdt has already achieved this?