Theralase Technologies Inc. V.TLT

Question for Eoganacht

[N0taP00p]

You mentioned in a previous post you estimate around 40-50% CR at 450 days eventually. You also mentioned Adstiladrin CR at 450 days is around 24%. How do you reconcile that against the FDA release which states "Overall, 51% of enrolled patients using Adstiladrin therapy achieved a complete response (the disappearance of all signs of cancer as seen on cystoscopy, biopsied tissue, and urine). The median duration of response was 9.7 months. Forty-six percent of responding patients remained in complete response for at least one year".  Is 46% CR at 12 months our comparable target?  Don't know how to read that.  It seems like the FDA is using the 46% CR number.   Any clarification appreciated. Thanks in advance.

[enriquesuave]

51% of these patients achieved CR at any time Vs our 65%  CR plus 12% iR.  Of these 51% Who achieved a CR status, 46% % remained CR for 12 months. 46% of 51% =23.5% overall.

[DJDawg]

Not Eog but hope it is ok if I chime in. 46% of responders (who are 51% of starting total) is a true CR of 23.5% They seem to like selling the percent of responders that are still CR as number looks better. Using some terminology for Ruvidar. "60% were responders at 90 day and at 450 days 57.9% of responding patients were still CR." Our 60% and 57.9% beats Adstiladrin's 51% and

[plantrader]

DJ, the quote that NotPoop showed says "enrolled patients" not "responders". It sounds like he's asking whether that's their durable response #?

[N0taP00p]

Plantrader - thank you. Sometimes it's hard to know how or what to ask. Let's see what the feedback is for your additional clarification. 

[DJDawg]

Not sure exactly what the question is. Enrolled is the ones that started and got the treatment. Responders are the subset that responded. Then a portion of the responders kept the response. Durable response is a definition I've never liked based on how it is used. Keep in mind that it also get confusing since some will use percent of "evaluable patients". Eog may be able to make

[plantrader]

As far as I can tell, the question is related to the quote. 51% of enrolled patients. It says enrolled, not responders. 51% of enrollees would be astounding, right? Or did they really mean 51% of responders? Big difference. If we take the quote at face value then it's phenomenal, no? That's what NotPoop is asking, I believe. "Overall, 51% of enrolled patients using Adstiladrin

[DJDawg]

51% of enrollees end up being responders.  Achieving is CR is just the start. Then you have to hold that response. Ruvidar is achieving 60% of enrollees becoming CR which is better. Then the quote mentions that "Forty-six percent of responding patients remained in complete response for at least one year". So 46% of 51% is the percent of enrollees that are CR at one year plus

[plantrader]

@DJ. Aha, thanks! So they mean 51% of all enrolled patients end up being CR at any point in time. Right? And Ruvidar is at 60% for that same metric as you said. Thanks for the breakdown.

[enriquesuave]

Ruvidar has achieved 65% CR at anytime and that includes 12 undertreated patients, plus 12% IR

[enriquesuave]

I expect 75-80% plus, anytime CR excluding initial 12 undertreated patients.  IMHo

[N0taP00p]

@Enrique.  Now that would be something, wouldn't it? Even if we get to 60%, this should be a no-brainer. End of Q2 would be nice for submission, then they can ease up on the R&D spends and conserve cash, whatever's left of it. 

[BlueFranky]

Enrique, Eoganacht, C.S, DW, ScienceFirst et Al Given our current numbers Given our projections based on reasonable deduction Given the latest setbacks with our competition as of this week What are your thoughts about the possibility of being taken out before FDA approval? .. cuz I think that's a real possibility

[Eoganacht]

Great clarifications enriquesuave and DJDawg

[N0taP00p]

Thank you DjDawg and Enrique. Thanks for the apples to apples comparison as well. I hope the FDA sees it that way too. 

[N0taP00p]

@DJDawg. It's not that we like to do math problems while drinking on the weekend but humor me one more time, please. When you do the apples to apples comparison and say Theralase is CR of 57.9 % of responding patients, please tell me how you got that. I count 31 patients as CR at 90 days and 11 are CR at 450 days.  Where is that 57.9 coming from?  No answer is okay if you're

[DJDawg]

You are very right. I did not explain my math as clearly. There are 19 Responder for which we know the story all the way to 450 days. Of the 19, 11 keep their CR. That is my 57.9% To my mind we don't know the others so I was just doing the subgroup of responders and how that played out. As every CR at 450 was a CR at 90 I consider the 90 day CR's the key. All the other CR's that

[N0taP00p]

@DJDawg.  The only way I see that 19 responders number is if we ignore the first 12 under treated patients. If that's what you meant, I get it. Maybe I missed it above.  So TLT has more than the 25- patient data stipulated, even with the 12 removed. And the CR numbers at 450 days are better than the competition. Even if the 12 are added back into the count, we're still above 30%

[DJDawg]

The way I came up with 19 responders for which we have all the data is to look at the swimmers plot in May 10 press release. I duplicated the May 10 swimmers in excel format it as an image URL if you want to see it that way. https://i.postimg.cc/JhnQVSzT/May-10-Swimmers.jpg I looked at the patient for which the full 450 results were in. I counted the greens at 90 days in that group. 19 I

[N0taP00p]

Thank you DjDawg. That's very helpful. On a weekend too.