Theralase Technologies Inc. V.TLT

The Data

[Sunvalley]

 With regards to the 3.7% CR at 360 days and 450 days respectively , a shareholder friend  mentioned that those were not very good results for a CR after a year and thusly he is deterred from increasing his stock position. I could not argue with him and I was at a loss for a explanation as to how the Pending figure should factor into the equation. It seems that I am comfortable with the numbers in my head but I could not seem to explain it in laymans terms if you know what I mean. Does anyone have a simple way to explain this as I seem to have a mind block.?

[enriquesuave]

Simply not enough data at 360 days and 450 days.  At both of these time intervals, we only have data on 9 patients out of 27.  4 of these 9 were from the 1st set of undertreated 12 ( but received an Optimized maintenance treatment) and the 1 patient who died from the optimized group.  The next read out should show us data on 3 extra patients at 90 days, 7 at 180 days, 5 at 270 days,

[enriquesuave]

We must also not dismiss the fact that I believe 5 patients were wrongly dismissed from trial before there 2nd treatment early on as they were NR, but showed no progression.  They had to change protocol to allow no progressions patients to stay in trial for 2nd treatment.  So not only were they severely undertreated,but did not get a 2nd treatment.  Still we are seeing 25% CR

[enriquesuave]

Having pointed this all out I'm being realistic and hoping for 35-45% 12 and 15 months CR rate.  That would be way over 30% benchmark and with a One and Done novel procedure.  If it's above this number , than great, but anything significantly above the other single agents efficacy would still be excellent, and so far our numbers are beating.  All IMO

[StevenBirch]

I am sure these anomalies that you point out while not being taken into account by the market are well aware to the FDA and other trained eyes.  So while we complain about how the data is presented and needing to get more visibility to gain interest to get the stock more accurately valued I think what Dr. Mandel said, "I am encouraged by the clinical results to date" and Vera

[Infinity]

StevenB I do agree with you on this. I do have faith in Dr. Mandel's expertise and hope Dr. Vera Mazdervic will deliver the push needed in Clinical studies. I am yet to see any changes in trajectory in clinical studies since she took over. I am more concerned with what is NOT being said in these updates. 1. Move to Li Ka Shing knowledge and the benefits of association with St. Mike's

[Legit62]

enriquesuave, can you please apply to Theralse and publish the next data reults, the SP would be $3 now. We need a mind like yours in the company!!!!!!!!!

[blackjack0]

I will second that motion 

[Sunvalley]

I will second that,  Legit62.  if you put it in the form of a motion at the next meeting LOL.

[Infinity]

Enrique, That is a fairly accurate statement. Did not realise that the Data included 5 patients who were removed from the study, this completely makes any statistical conclusion skewed. The only way to draw meaningful conclusions would be to increase the sample size. We need more Patients in the study. One way to enroll more patients is to offer PDT as an option even before trying BCG. Considering

[enriquesuave]

Yes we definitely need a bit more data in the next readout we will see if the trend keeps up, then we know we are on track for sure.  So far CR's are going up.  From November until now we see an improvement and looking at 360 days data and 450 days data  in overall group on evaluable patients.                        

[Pandora]

So we have 20 patients that have reached 450 days? Presumably this includes 3 from Phase 1b (one dose?) and the first 12 from Phase 2 who were considered "undertreated"? and then 5 from Phase 2 who are considered to be the "optimized" patients. Am I understanding that correctly? i.e. 5 so far of the Phase 2 patients that are considered to be the true reflection of Phase 2

[enriquesuave]

No so far not enough patients  double treated in the Optimized group to determine a true reflection of this Phase2 trial.  However, in the overall group, even with the anomalies, we are seeing numbers that are so far beating the single agent  competition and we are seeing better numbers over time.  Hopefully that trend will continue.  

[Pandora]

Sorry I guess I just had my wording wrong. I guess I could have used the wording "will be considered" instead of "are considered". I was trying to say those 5 patients that are beyond the first 15 will be the first of those that will give a true reflection of Phase 2 qualification standards(?). As that number grows it gives results that have no 'questions' around their

[jicoop]

Hey Sunvalley, I posted a lengthy explanation 3 days ago, giving my take on the numbers. here is a snipet from that, and you can forward to your shareholder firend if you like.  Coop 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

[Sunvalley]

Good Morning Coop. Thank you for this. I am away a lot and I missed this somehow. I will relay the message and  appreciate you permission to do so.