RE:RE:RE:RE:RE:Very Good News!Misleading on Press release, but it seems 23.5% of patients maintied CR for 12 months or more, we still beat them. Those who didn't get CR, but showed no high risk of progression were offered to continue treatment after 12 months. 11% had serious side effects. We are much better in all aspects IMHO the FDA now has something we can be compared with and if better, it should be a no brainer.IMO
https://www.fda.gov/media/164029/download enriquesuave wrote: I believe Adstiladrin CR rate is 23.5% at 360 days and probably less at 450 days. It seems clearly laid out. We already beat them and will most probably be 100% more effective and half the treatments. Also no restrictions on immune compromised patients. Blackrock invested $450 Million in Ferring to market Adstiladrin 2 years ago, before they got a CRL for manufacturing issues after they filed their BLA. I guess they resolved these issues. We will only need an NDA much much simpler than a BLA. Big Pharma might start looking a little closer as this approval bodes very well for our TLD-1433 and it's much higher chances of approval and marketing success as the FDA has now expressed that our CR rate is definitely a done deal, as well as our safety, patient friendly (One and Done plus a One and Done maintenance), as well as easy as can get manufacturing of drug. All IMHO but can't get more derisked as long as we keep up similar data on optimized patients.
DJDawg wrote: I was curious about the drop off in CR over time. I couldn't find it for the most recent data but interestingly the 157 patient response mentioned above is similar to the smaller patient data reported earlier in 2021. 151 is very similar to 157 but the CR is different between the 51% CR reported here vs the above reference.
| Recurrence-free survival (months) | CIS + /- Ta/T1 (n=103) | Papillary disease (n=48) | Total (n=151) |
| 3 | 53,4% | 72,9% | 59,6% |
| 6 | 40,8% | 62,5% | 47,7% |
| 9 | 35% | 58,3% | 42,4% |
| 12 | 24,3% | 43,8% | 30,5% |
In real terms
90 day CR was 59.6% OR 51% (two different numbers out there) vs our 53% (non optimized included)
180 day CR was 47.7% vs our 45%
270 day CR was 42.4% vs our 41%
360 day CR was 30.5 vs our 29%
450 day not reported from this group but above say 46% of initial 51% which is 23.5% vs our 28%
So very very similar. Our still has 1-2 and done advantage. Ours, when optimized is obviously higher.
So much time and success lost on those 12 non-optimized patients. sigh.