RE:RE:RE:RE:Financials are out on SedarAwesome! And the FDA criterion for accelerated approval of drugs for serious conditions that fill an unmet medical need are quite liberal:
"Using surrogate or intermediate clinical endpoints can save valuable time in the drug approval process. For example, 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. In this example, an approval based upon tumor shrinkage can occur far sooner than waiting to learn whether patients actually lived longer. The drug company will still need to conduct studies to confirm that tumor shrinkage actually predicts that patients will live longer...." We could be headed for a CR of 50% at one year for the first 25/28 patients even without taking into account the false start. This sort of preliminary result would more than satisfy the criterion of a reasonably likely real clinical benefit!
enriquesuave wrote: Yes that's Q1 and results look amazing to me. So far 7 patients out of 22 are CR at both 3 months and maintained at 6 months.( that's 2 from PH1 and 5 from PH2).. Also 2 PR or partial responses are still PR at 6 months ( indicating they have a clean cystoscope exam and only urine cytology is positive), which is also amazing as there is a good chance that they have UUTUC rather than bladder cancer and may eventually be counted as CR. 4 patients are still pending 90 and 180 days so numbers can go up. Given that 5 patients were wrongly dropped from trial early on given severe underdosing of 1st 12 patients, results look pretty awesome I would say. We see high efficacy and a durable efficacy. None of the competitors show the same durable efficacy from 3 months to 6 months all drop from about 45% to 30% and drop further to 15-24% at 12 months and even further at 450 days. This awesomeness should be confirmed after we see data from pending patients IMO.