RE:RE:RE:The Theralase Project enriquesuave wrote:
"Yes definitely thought provoking. I still see TLD-1433 shaping up to be the best single agent/best option for NMIBC BCG Unresponsive. Data will hopefully confirm this going forward. The glitches have been taken care of after 35 patients. We must not forget that given the small PH1 of only 6 patients, it was hard to correct any potential errors in protocol with such a small sample. Although they had done one Optimization, I think going forward with PH2 Optimisations, we will get there.IMHO"
Yes to all of the above...
Based on current data, our BTD/FDA approval chances are quite good imo when you consider what the current "available" therapies/options are: 1) losing your bladder & 2) Keytruda....neither of which provide a decent quality of life imo.
Focusing on Keytruda, we're all aware of the fact that it recently set a new low bar with a 12 month CR of 19%. But not everyone may recall that patients must endure an IV infusion over 30 min. every 3 weeks for up to 24 months.
And it's hard not to overlook the other low bar set by Keytruda in terms of safety. Serious adverse events occurred in 28% of patients...& many of these events had nothing to do with the bladder. These adverse events included pneumonia, cardiac ischemia (inadequate bloody supply to the heart), colitis, pulmonary embolism (blood clot in the lung), sepsis & urinary tract infection. Furthermore, treatments had to be interrupted in 22% of patients due to various side effects (commonly diarrhea). Lastly, 11% of patients had to discontinue treatment altogether...most often due to pneumonitis (inflammation of the lungs).
The FDA takes as hard of a look at treatment responses as they do a drug's safety profile. Our ACT's ease of treatment & quality of life during treatment should also weigh positively on any FDA or other regulatory decision. I'm all in. GLTAL!