RE:FDA stanceN0taP00p wrote: If you look up an article titled "FDA Is Speeding Up Review of Padcev-Keytruda Combo for Bladder Cancer" and another one about Ferring's recent gene-therapy drug approval for BCG-unresponsive NMIBC titled "FDA approves gene therapy for bladder cancer" you see a commitment from the FDA to expedite reviews where there are unmet needs. They clearly saw enough in phase 1 to give Theralase a fast track and come back with data on 20-25 patients. Inclusive of the 12 under-treated, there's enough data by now for 25 patients. Only question is, is Theralase waiting for data from 25 patients who all got correctly dosed, so as not give the FDA any cause for concern (though you would think there shouldn't be any). The safety profile, efficacy, ease of procedure and duration all seem to indicate it should be a positive nod, even with the under-treated data. The hope is the FDA does not suddenly relax, thinking there's two treatments out there already approved for BCG-U NMIBC, and so this one gets the "show me more data" treatment . The unknown unknowns.
I don't thik TLT is waiting on those additional patients. Remember, even with BTD the Phase 2 continues, and the CR numbers will continue to improve. I still expect AA sometime this year. Ferring has an interesting drug. Tho it does take many treatments, copared to TLTs 1-2 and it is somewhat toxic compared to 1433. I expect TLTs 12 month CR numbers to improve till they are considerally better than Ferrings.