Theralase Technologies Inc. V.TLT

Let me try again.....

[greaterfoolFred]

Hello All,

THE DATA RELEASED THIS WEEK BY THE COMPANY IS WRONG.

The swimmers plot is misleading because, when a subject becomes NR and there are no further examinations, they are not shown at subsequent time intervals.   Even though they are not shown at subsequent intervals, they still have to be counted at those intervals when calculating numbers and percentages.  The person at Theralase who compiled the data table just counted up the dots on the swimmers plot for each time interval and calculated percentages, forgetting that NRs had to be carried forward to subsequent time intervals.  THEY LEFT OUT MANY NRs WHICH SHOULD HAVE BEEN COUNTED.

It's simple to fix.  On the swimmers plot just carry all of the NRs forward to the appropriate time; their number of days in the study.  THEN you can just add up the number of subjects in each catagory at each time interval and calculate percentages.

Comunications from this company are pathetic.  And the data table in question was NOT compiled by a Principal Investigator, or anyone with any education in math or science. I hope this is not the table that will be presnted at the upcoming meeting.

Sorry about all the caps; reminds me of another poster that we haven't seen for a while.
Good luck All.

[consultant99]

I assumed the company knew what they were doing in how they presented the information. Your theory is the way I would have expected them to present the data If they screwed this up it is a significant blunder.

[gojotv!]

Uh-oh... don't tell me you shorted your shares before the news release... That's so harsh, dude.

[DJDawg]

I respect many on this board but I have to agree that the swimmers plot translated to the table makes sense in the ASCO poster. Once someone was NR that NR was carried all the way to the end. Then, the changed the methodology in the MDA so that the concordance between swimmers plot and table didn't make sense the same way. I doubt that the poster at AUA will make the same mismatch so it will

[Johnandrose22]

Applause, Fool....Applause!!...You're deception is noble...We'll done!

[Johnandrose22]

Fredgownsen??.. My apologies for the abrupt response...if this is your legitimate concern than you have my respect and interest.

[Rumpl3StiltSkin]

Fred, I don't think it matters as I believe they are using the correct and full data to apply for BTD and AA. If they have some new way of presenting the data moving forward? I guess as long as the FDA and other regulators are ok with it why not? At least it eliminates the 12 undertreated. That doesn't mean they didnt mess up the swimmers plot. It is very confusing to me.

[enriquesuave]

Math is simple, but there still needs a few details to be clarified.  Last November 51 patients had been treated in PH2 plus they were counting the 3 from PH1 for a total of  54.  Now they have not mentioned 3 from PH1 and are simply stating that 57 patients have been treated in PH2.  Plus they are removing patient  that died, so a total of 56 patients ( includes 12

[CancerSlayer]

As noted previously....looking at the entire Ph 2 data set (including the first 12), it is reassuring to know our treatment is showing a relatively high durable response....if a patient is CR at 90 days, there's a good chance he remains CR.  Of the twenty-four 90 day CRs who have been assessed at a later date, only 5 (~20%) have eventually converted to NR.  71% (17 of 24) have

[99942Apophis]

Thanks for your insight CancerSlayer,  my non medical brain can't understand if this treatment is done correctly and produces a CR in a patient then how does the cancer return giving that person a NR. In my way of thinking cancer can only return because the bladder wasn't filled to maximum and remained undetectable within a fold thereby producing a false CR is this plausible? Please

[DJDawg]

I work in a medical area that deals with cancer among other things. Whenever a patient is in remission from cancer it means that, as far as we can tell, it is gone. But the limit is whatever technology we have. An MRI scan may show breast cancer all gone. However if there are tiny clusters of cancer cells somewhere there, sometimes in a quiet phase of growth, then, the cancer may come back

[Oilminerdeluxe]

Perhaps the returning cancer has migrated from places in the body?

[99942Apophis]

Thank you DJDAWG that explanation makes perfect sense and greatly improves my understanding.  

[Eoganacht]

Good post DJDawg. Thanks for sharing.

[enriquesuave]

There is also the possibility that a patient is CR, but is counted as IR as cancer cells  coming from the UTUC are detected in Urine.  Eventually reseeding of cancer cells on bladder lining can cause a new Tumor lesion.  I wonder if they map out bladder and see if the same lesions are still there ofr new ones?  An IR patient who becomes NR, may have been CR in actual fact but

[CancerSlayer]

  Per FDA's 2018 guidance letter: "Bladder mapping and random biopsies in patients with CIS should be performed before trial entry (Gudjonsson et al. 2012)."  

[enriquesuave]

Nice find!  Good because new lesions in IR patients could simply lead to false NR patients over time and who should have been classified as CR. IMo

[CancerSlayer]

  I'm not DJDawg, but I agree with his answer for the most part. Small clusters of cancer cells can evade current diagnostic capabilities.  The diagnostic tools used today are improving, but none of them are 100% sensitive.  They will always carry a false negative rate (i.e. cancer present but was not fully identified).  This is the likely case for us imo.  The

[99942Apophis]

Thank you CancerSlayer for that answer. Your comparison to overuse with antibiotics sends a clear picture of how to render a great medical treatment into a non effective one in the whack a mole overuse,  however in an attempt to ward off death whack a mole is still a viable option perhaps in a limited consideration.  AUA being held in Chicago could bring media attention to Theralase, a

[CancerSlayer]

  Yes...I didn't intend to discount the need for repeated treatments in many instances.  Historically, such an approach has proven itself.  I was just highlighting the potential drawbacks of such an approach.  This is where I believe combining therapies that use different pathways/mechanisms of action &/or delivery methods can perhaps improve overall treatment success

[99942Apophis]

I understood what you were saying,  your comparison to antibiotics was perfect. A few decades ago while in Isreal I met an Isreali surgeon who had the same observations as you. I took his advice and only used antibiotics in absolute required instances,  I was surprised at how many doctors back then were prescribing for minor infections.  Yes everything must be weighed to decide what

[CancerSlayer]

  Yep...over-prescribing & repeated treatments over the years have created a unique obstacle in medicine.  The delicate interplay of our body's own defenses & that of medicine determines every treatment's ultimate success.  Too much or too little of either will upset this delicate balance...   More of the same (ad nauseum) is not always better, & when

[StockinFocker]

greaterfoolFred wrote: "The swimmers plot is misleading because, when a subject becomes NR and there are no further examinations, they are not shown at subsequent time intervals." ----- IMHO: I think they do get shown at subsequent time intervals, but only after the patient has actually been in the study for that (later) time interval, and not before.  For example patients 11 and

[wildbird1]

Excellent post StokinFocker. If you look at the swimmer plot chart, patient 22 is NR at 90,180,270,360 days and will certainly be NR at 450 days. This patient no-22 indicate that Greaterfoolfred is trying to mislead peoples on this board by pretending that NR patients are not carry forward.