Theralase Technologies Inc. V.TLT

Upcoming CR % @90 days = 71%? Extrapolation on 100 patients

[ScienceFirst]

Corrected some typos (CR vs TR).  No change to %s.

_______________

TR = CR + PR.  And TR is what the FDA is focusing on.  Not just CR.

In the latest update of August 30 2022, there were 7 patients with a pending status, out of the 45 patients treated. 

We had 66% TR, out of 38 evaluable patients.   

The break down was like this:

50% CR (so 19 patients)
16% PR (so   6 patients)
66% TR (so 25 patients (19 + 6))

That means 25 TR patients.  Chances are excellent that these 7 pending status patients all turn TR (in a mix of CR and PR).  We would then aim for a 71% TR ((25 + 7) / 45).  That would be excellent and unheard of.

 

Here's though different legitimate scenarios regarding the change of status by these pending status patients: 

 

- if 7 out of the 7 pending patients turn TR, then we hit 71% TR (@90 days)

- if 6 out of the 7 pending patients turn TR, then we hit 69% TR (@90 days)

- if 5 out of the 7 pending patients turn TR, then we hit 67% TR (@90 days)

- if 4 out of the 7 pending patients turn TR, then we hit 64% TR (@90 days)

 

That would not be much of a change versus the 66% TR of last August, but that would tell us a lot about a fairly good reading on what the optimized group could be trending for, for a pool of 100 patients.   

 

- 7 out of the 7 pending patients turn TR, then we hit 100% TR (for this pool of 7 pending status patients)

- 6 out of the 7 pending patients turn TR, then we hit   86% TR (for this pool of 7 pending status patients)

- 5 out of the 7 pending patients turn TR, then we hit   71% TR (for this pool of 7 pending status patients)

- 4 out of the 7 pending patients turn TR, then we hit   57% TR (for this pool of 7 pending status patients)

We could then "extrapolate" where we could land with 100 patients, for example.  We already have treated 45 out of these 100.  So 55 remain to be enrolled.

 

For example, if we have 55 additional patients @86% TR, that would represent 47 TR patients.  Adding them to our existing 32 TR (25 + 7) out of the 45 evaluable ones of late August, we would end up with 79 TR out of 100 patients.  So 79% TR.
 

- 100% out of the 55 pending patients turn TR, then we get 55 new TR.  Added to our 32, we get 87% TR for 100 patients
 

-   86% out of the 55 pending patients turn TR, then we get 47 new TR.  Added to our 32, we get 79% TR for 100 patients
 

-   71% out of the 55 pending patients turn TR, then we get 39 new TR.  Added to our 32, we get 71% TR for 100 patients
 

-   57% out of the 55 pending patients turn TR, then we get 31 new TR.  Added to our 32, we get 63% TR for 100 patients

So lets see next week how these 7 pending ones turned out to be, as it could help us make some extrapolations.

But unless we have unexpected instability, I would say that our clinical trial, once completed (2025), could show a TR % (@90 days) of around 70%+.  Given that we had 12 undertreated patients, right from the start of our Ph. 2, that would be impressive.  And even 70%+ for only the optimized group, that would still be unheard of.

[CancerSlayer]

Nice post SF....the FDA will be looking at more than just the CR rate.  In their 2018 guidance, the FDA specifically stated that a treatment's real-world effectiveness/progression-free disease (& not just a response rate/efficacy) will play a role in providing supportive evidence for an approval.  I also believe the FDA will not only be focusing on clinical/efficacy value of a

[BlueFranky]

Cs and SF Got to thank you two again for your ongoing tireless efforts in sharing your insight with all of us. You're both much appreciated. Have a great weekend Blue

[stocksnbonds458]

I second those those thankyou's to CS and SF. I think that early 2023 will be very exciting. I would also add enriguesauve and Owen of Munster to the list of people on this board whose insights have been of great value. 

[Rumpl3StiltSkin]

I've been here as long as you and Skier S&B. Who is Owen of Munster?? :-)

[stocksnbonds458]

Eoganacht. The name of a 1200 year old Irish dynasty from Munster. Eogan is pronounced owen. At least that's one description of the name.  

[Infinity]

I believe your thoughts are right on target.  FDA relies on multiple factors including influencers and lobbyists hired by Major Pharmas.....

[enriquesuave]

Given a high efficacy and safety after only 2 treatments it should be easy to argue to have patients the opportunity to get a 3rd treatment in real life if not CR after 1st 2 treatments. Could the  FDA could suggest a 3 rd treatment if one is still not CR at the 9 months mark? IMHO.   

[Yajne]

Very interesting post enrique. Given the excellent safety profile of TLD-1433 (lack of side effects), it seems to me that you are on to something. We have been focussed on one or two treatments, but it seems to me that additional treatments could be administered with very low risk.