RE:RE:Misdiagnose???Inclusion Criteria: Have no evidence of upper urothelial carcinoma within 3mos. of treatment initiation.
It's noted that P1 and 2 have a previous history of uutuc. So, according to the Criteria at 3mos prior no indication of uutuc? Then between 3mos and treatment initiation uutuc returned ?
Recurrence Free Survival (RFS) defined as interval from day 0 of treatment to documented recurrence.
Exploratory: To evaluate Efficiency as measured by RFS.
From what I can see, 0-90 days success at all three levels for p1, 2, & 3. Number 4 some inflammation.
Then the cheese gets a bit more binding.
From 90-180 days p1, 2, & 3 failed RFS within that timeframe.
P1 & 2 with previous history of uutuc brings up the possibility of seeding, although p3 mentioned at hi risk does not have a history of uutuc but is included in the seeding theory.
I go back to the Inclusion Criteria which does seem to be relatively rigorous in its objectivity except for that three month window which looks to me as pretty wide.
The Discussion in the NR I think leaves something to be desired. The inclusion of those probability words, may and possibility, gives the impression that the company is trying to dress up the results with a rather broad interpretation taking the whole thing from objective to subjective.
Let's hope the Therapeutic dose keeps uis on track.
vestor111 wrote: I raised the issue of potential misdiagnosed some time back and not without reasonable cause.
If you reread the Nov 8th release, it appears there is a lack of definitive conclusions on exactly what the patients have because some had "a history" and the others were "at risk". This wording appears far from definitive so it appears there is a degree of subjectivity in the diagnosis. Cost and difficulty issues may prevent this. But this lack of hard science definity lends itself to the possibility of misdiagnosis.
As I have stated, I done blame the company or PMRI - it is the nature of the beast.
But as you point out - ph1 is all about safety and tolerability first and foremost. And so far, TLT is coming up aces.
Hopefully in Ph2, there will be some latitude to address suspected UUTUC patients to help devise a better understanding (this hope I have also posted) and over time perhaps some specific techniques will be devised to insure better treatment.
From the cheap seats - close to the mushroom farm.