RE:RE:RE:TLT Conclusion - On a good track...Ok, so my take on the numbers portion , which hopefully adds to the info presented so far today by Pandora and couple others. Note, I am not a scientist, just a number cruncher , and I will summarize as quickly as possible .
Firstly, The optimized table seems to present worse results than the first non optimised table, not sure why that is, Company would have to answer. I will concentrate on the numbers in the optimized table.
The first scary number that jumps out is CR of 3.7 % , but what is that number really. In fact , it is 1 patient out of 27 presented as a percentage. The first BIG problem is that in fact, according to other numbers, only 9 patients have reached 450 days out, and if you redo the math, 1 patient in 9 is presented later on in the table under CR ( Evaluable patients ) with a number of 11.1 % .
I think the 3.7% is misleading, as you cannot include them in final statistics if they have not reached the statistical endpoint. It's like a marathon of 27 runners, and only 1 of 9 known runners have finished, 8 did not make it, but therer are possibilities for others to make it all the way, so can you say only 1 in 27 have finised the race ? I think not .
Now back to that analogy, how many are still in race ? Well math tells me 18 others are still in the race, but not all will make it to the 450 day line succesfully ? How many have a chance ? The pending column correctly show 66.7 % , which correponds to 18 out of 27 , but the real question then is how many make it to CR at 450 days from theat group.
Now it gets a bit tricky, where do the other 18 stand ? My first take is that 18 patients have made it to 270 days, and 3 of them were CR at that point . How do I make that assumption, take the 27 totals patients, add the 3 from the 18 , and the one patient from the 9 group, and that gives you 4 patients total out of 27 reported at 270 days, which gives a 14.8 % , as you can see in the table in the 270 row under CR .
So how many of the 3 remaining have a chance to get CR at 450 . I beleive this number is 1 or 2 , a bit of a guess here I admit.
Hope this has not confused anyone further, but has helped at least expain the %'s a bit better .
Guess the question to answer in the end will be, if they present 100 patients who have failed the BCG treatments, and are told you can either have your bladder removed , or try this treatment that has saved bladders at a year and half out with CR result, what would you choose, if you can say that somewhere between 10 and 20 of the 100 will keep their bladders without issue for at least 1.5 years .
I'm rambl9ing on now, got to cut out the coffee and maybe divert my attention to picking a winner for the Masters !
Coop
Pandora wrote: riverrrow wrote: As usual the data appears muddled. Personally I can't make heads or tails of it. GLTA.
And I believe that is the main reason for the market reaction. First off there are those that had visions of sugar plums dancing in their heads and the news today does not confirm the sugar plums.
The data is not presented in an easy way for novices to understand and I have to believe the shareholder base includes a large number of novices.
From my own perspective a couple of points I find confusing. They start off by defining Study II as being 35 patients but then roll 3 patients from Study 1 in and then go on to refer to 38 patients in Study II. I also believe, but am not sure, that the one adverse event at Grade 5 (Death) is from Study 1 - but that is just going by memory.
The chart then goes on to refer to all patients on a percentage basis but does not clearly define the 'number' of patients that have actually achieved each base point. i.e. of the 38 (or 35) how many have achieved the 450 days, the 360, 270, and 180 days? As novices many of us cannot really say based on the makeup of the data -- i.e. confusion. And in my mind adding the 3 additional patients in from Phase 1B just adds a little more confusion to the overall.
To top that off the first 12 of the 35 in Phase II did not receive the "optimized" treatment intially.
The body of the statement gives the numbers of the patients as follows:
"The Study II optimized treatment patients, who received either an optimized primary study treatment or optimized maintenance study treatment consisted of: 23 patients at 90 days, 26 patients at 180 days and 27 patients at each of 270, 360 and 450 days."
The charts themselves under column one (Assessment) do not define how many patients fall into each category of days. To me it "appears" from the above data that 27 patients ( 3 from Phase1, 12 from the less than optimized group, and 12 from the optimized group) make up the data on the bottom 3 lines of the chart -- but from a novice like me I am just essentially guessing at that because I am confused. The first chart does not have a date on it. The second chart says "Post August 1, 2020") which, to me, again adds confusion.
I would say from my perspective that the inability of a very large number of investors to be able to read and understand the data, results in the intial market response that we have seen. I could be completely off base so offer apologies if I am. Also, the fact that there is one Grade 5 cited as part of the data does give a negative tone, and it may be a bit misunderstood as to the source, but it has an impact.
All in my humble opinion.
Patients #13 through #35 (23 in number) in Phase II are the highlights that will set the tone if we can filter them out but the "Study" must lump all data together. (38 patients thus far - 3 Phase 1b, 12 Phase 2 - less than optimized, 23 Phase 2 - optimized). ??