Ph. 1b P#6 @67 days ... FredGoodwinson ... Great reminder and perspective regarding the fact that P#6 databack then was after 67 days or so..
This clearly went unnoticed back then. Just like the 540-day data, given the little reaction from the market.
For sure, that 67-days data was a brilliant signal that inflammation will not an issue with this technology, contrary to BCG, where urologists don't even waste their time trying to cystoscope patient before 3 months.
The Ph. 2b trial record states that they will check for efficacy at 7, 30, 60, 90 days. For sure, they will want to demonstrate as much as they can where inflammation is gone, to assess another very important edge over BCG.
So one day, we will hear more about what looked like the bladders @30, 60 days. And hopefully also @7 days (though I remain skeptic about that one, for imflammation to have completely disappeared). But hey!, we're allowed to be curious.
Especially when you look at Fig. 3 of this Feb. 2019 Keytruda data, where Merck shows "Time to CR and time to recurrences":
ASCO GU 2019: Updated Results of Keynote 057: Pembrolizumab for Patients with High-risk Nonmuscle Invasive Bladder Cancer Unresponsive to BCG
This Fig. 3 will tell it all, the day we plot our data against Keytruda's one.
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fredgoodwinson - (12/5/2019 10:47:46 AM)
RE:Here's why I think we should wait for--- These were the headings of the ann of the 18th of April 2018:
Patient Five Shows No Clinical Evidence or Presence of NMIBC at 90 Day Cystoscopy Analysis
Patient Six Shows No Clinical Evidence or Presence of NMIBC to Date
These words ‘No Clinical Evidence or Presence of NMIBC’ were only ever used for Patients Five and Six so if we see them used again we can draw our own conclusions. Patient 6 was treated only 67 days`before this announcement was made. These initial analyses remained unaltered at 18 months.
In his lecture in Paris on the 12th of November 2019 Dr.Lilge stated that:
‘Theralase is continuously improving the quality of PDT treatment with TLD-1433 and the optimized TLC-3200 laser system.’
He would not have been able to say this if the initial Phase II readings had been any worse than those taken for Patients 5 and 6 in Phase IB.
Again we can draw our own conclusions. Wonder if many of the Triallists will need that second treatment at 180 days and whether Investment Analysts will ever pay attention to any of this?