RE:"impressive, paradigm shifting, photodynamic therapy"
Eoganacht wrote: Michelle Carr February 23, 2023
Research Capital likes the potential chances of Theralase Technologies’ (TSXV:TLT) Ruvidar photodynamic therapy being better than Merck’s Keytruda for treating Bacillus Calmette-Gurin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC).
In a new research report, analyst Andre Uddin, Ph.D., writes that Theralase recently presented more positive data at the 2023 GU ASCO conference that continues to highlight their “impressive, paradigm shifting, photodynamic therapy” for treating BCG-unresponsive NMIBC.
“Based on the data presented (while we are somewhat comparing apples to oranges and the sample size is smaller) – new Kaplan-Meier curves and swimmer plots showed a complete response duration that has the potential to be better than Merck’s Keytruda for treating NMIBC,” Dr. Uddin said.
He said the data generated to date shows that Ruvidar’s efficacy is strong and durable, with a clean safety profile for this patient population.
“If this trend continues, we believe Theralase’s Ruvidar (TLD-1433) has the potential to be better than Merck’s Keytruda and expect Ruvidar to launch in 2026,” he added.
Dr. Uddin rates Theralase as a “speculative buy” with a price target of 80 cents. The stock closed at 39 cents on Feb. 22.
Per Dr. Uddin...
"If this trend continues, we believe Theralase’s Ruvidar (TLD-1433) has the potential to be better than Merck’s Keytruda and expect Ruvidar to launch in 2026"
It seems Dr. Uddin believes Theralase is headed towards a more traditional approval (i.e. data on 100-125 treated patients). He has mentioned "2026" on more than one occasion. If one looks at all other recently approved/applied-for drugs to date, they have required a similarly large sample size....not sure what to make of this other than the FDA is perhaps taking the stance that a minimum sample size of 100+ patients studied (in a Ph 1/2) better satisfies the criteria of an AA/accelerated pathway?
Though I remain optimistic we have the potential to qualify for an AA with fewer than 100 patients, I'm not certain what the FDA is currently considering an acceptable sample size based on Dr. Uddin' s recent "2026" comments....perhaps explains the suppressed sp/ridiculously low price target? I tend to be more optimistic...