RE:RE:AGM Hi Fred....a very positive takeaway imo is the fact that we are even considering submitting an app for a BTD that includes a significant portion of under-dosed patients (nearly 50% of the total). As you know, consideration of the above app submission wasn't solely a company-driven decision, but rather resulted from guidance from the FDA. Imo, to give the above guidance for such a small & less representative sample of patients highly reflects the collective confidence in this new ACT.
In a worst case scenario, if the CR/durability percentages of the first 25 treated somehow didn't meet a minimum threshold, I'd expect any further review would appropriately rely on more fully optimized data. However, the above scenario is very likely "not" going to be the case imo based on the fact that of the 20 patients who have reached the 450 day mark thus far (12 of whom were under-dosed), remarkably 25% of this predominantly under treated group were able to maintain a CR (a 25% CR rate as reported in the 5/30 MD&A). This is a 31.5% higher CR rate than the latest non-BCG dependent/single-agent competitor (aka Keytruda)...a burdensome treatment protocol that is only given systemically & thus carries with it the increased potential for systemic side effects. All imo.
I'm also feeling pretty good about the fact that there is only one other single agent/intravesical option currently FDA approved. That is Valrubucin, which also poses little competition considering it historically provided what would be considered inadequate cancer control with a 12 month CR rate of 13%. Good luck...
fredgoodwinson wrote:
That would be helpful Dawg. A flurry of insubstantial anns in advance of an AGM is rarely a positive.
Everything - even the potential blockbuster Rutherrin (not even Tox studies after 6 years` plus?) - has been sacrificed to the NMIBC Trial so wary that no mention of BTD or AA in the ann of the 21st and as mentioned here just now the rate of recruitment to the Trial looks to have slowed markedly.
If could have got there and asked anything it would be:
'Are we still on schedule for BTD in 2022 and if not when?'