Theralase Technologies Inc. V.TLT

66% the number to beat...

[wildbird1]

In the 2Q2020 newsletter, page 3 under "FDA status update" Theralase said" Theralase would potentially be eligible for BTD & AA, if TLT could demonstrate clinically significant results, similar to the safety and efficacy results(66%CR) observed in the phase 1b NMIBC clinical study at an interim analysis of approximately 20 to 25 patients."

Let's see what advantages phase11 has over Phase1b...

Phase 1b                                                          Phase 11

Number of patient treated.   
6 .....................................................................30(and growing).

Number of treatments.
1 .................................................................... 2 (0 and 187 days)

Optimized treatment.
NO .................................................................YES

Optimized laser.
NO .................................................................YES(Pressrelease June 27, 2019).

Doctors experience working with
patients &TLD-1433.
Little experience..............................................Approximately 5 years(big difference).

CR%.
66% ................................................................??? 

The phase1b 66%CR was achieved with only one treatment, using a non optimized treatment, a first generation laser, and the doctors had minimal experience working with TLD-1433.

Note:The second treatment at 187 days will increase the CR% big time at 270 days. 

With all the positive changes made in the phase11 trial, there is no way the CR% is going to be under 70-80% CR.

[Paradise818]

Crossing my fingers your right. 

[Oilminerdeluxe]

Same here. Maybe next week is the one to shine.

[floatinketucky]

"similar to the safety and efficacy results(66%CR) observed in the phase 1b" So they just need toppling data better than the competition.  At the time that was the only number out there. Now we know the mark the comp has thrown and  our true arrow is about to fly and land enough above the comp for market domination.  We do not have to beat 66 percent .. .there

[hurko87]

This post has been removed in accordance with Community Policy

[CancerSlayer]

Based on the data thus far from optimized patients, it certainly looks like a threshold we can beat. In view of the natural/lethal course of BCG-unresponsive CIS & the negligible efficacy/limited number of available "non-invasive" treatment options, the FDA gave appropriate guidance imo.  It states it does not recommend or require any pre-specified response rate.  Such

[Eoganacht]

I agree that "the threshold for approval is likely significantly less" than 66% if we are talking about the percentage of the 100-125 patients in the trial who end up having a CR at 450 days. The 66% refers to the percentage of 20-25 patients who are CR one year after their first cystoscopy which the FDA communicated was required in order for them to grant us early approval. This

[wildbird1]

Eoganacht I agree the 66% quote by TLT was specifically about the BTD approval. The higher the CR% is the faster the BTD will be awarded by the FDA. In the 3Q2021 newsletter, Dr.Vera.Madzarevic (TLT director of clinical development ) said " BTD from FDA very soon". "Very soon" could indicate that at the time Dr. Madzarevic knew that 66% would be easily surpass, and as we speak

[Oilminerdeluxe]

Sadly, the word 'soon' in TLT-speech means 'eons' in English. Dear Lord,  one would think a guy who has waited all these years should not be as impatient about this next update, but I am literally going bonkers from the wait. Yes, the longer than expected wait could be because really good news is on its way. And yes it could be because of another mess-up or something else

[CancerSlayer]

  Appreciate your input...per the 2Q 2020 newsletter: "It was further discussed that Theralase would potentially be eligible for Breakthrough Therapy Designation (“BTD”) and / or Accelerated Approval (“AA”), if Theralase could demonstrate clinically significant results (high safety profile and high efficacy response), similar to the safety and efficacy results observed in the Phase

[Eoganacht]

Hi CancerSlayer, I just saw your post. I'm stilll hoping Theralase gets that 66% CR in 25 patients at one year. If not maybe the FDA  will lower the bar. 66% of 25 patients (17 patients) may seem like a pretty small number of patients to base approval on but Keytruda only achieved this number of patients with their 19% at 12 months. I agree the FDA "established a de facto

[99942Apophis]

Good discussion today. Within the first group of 12 patients 5 were removed from the study however 3 patients from PH1 are included giving us a total of 9 to get to the desired number of 25 patients  the magic number must now reach 27 patients!  One thing that bothers me is that for BTD it doesn’t really insist on the first 25 so if Theralase has treated 3 in Phase1  and up to 30

[floatinketucky]

Theralase would potentially be eligible for BTD & AA, if TLT could demonstrate clinically significant results, similar to the safety and efficacy results(66%CR) observed in the phase 1b NMIBC clinical study at an interim analysis of approximately 20 to 25 patients."