Theralase Technologies Inc. V.TLT

Upside to CR

[Donein25]

Imagine what the CR % will look like when we start retreating patients who have a recurrence, and they then show a CR at their next scheduled follow up?

Hard to imagine that the Amendment wasn't granted due in part to a strong consensus that the treatment is so effective that an additional 1 or 2 treatments will likely also benefit those patients who were NRs.

[Eoganacht]

I wonder....There were 13 patients who were NR from the get go who have reached 450 days. How many of those 13 might have experienced a CR if they were eligible for up to 3 more treatments? All of the first 12 undertreated may have ended up getting 2 full treatments. In the swimmers plot there are 24 NR red dots at 450 days. They can't all be patients with UUTC. If even a few of them would

[enriquesuave]

I agree,  The PI will be able to decide if a patient needs 2 more treatments and also the timing of those treatments.  So a patient who is NR at first assessment at 90 days may get retreated right away and maybe a 3rd  treatment 6- 8 weeks later?  This would be the ideal in order to give it another go at eradicating the CIS Tumors and boosting the immune response pretty much

[N0taP00p]

So Eoga and Enrique, what does this all mean to the timeline.   How much more time are you thinking if this, all of a sudden, needs to be part of a BTD application? Another 6 months, a year?  Trying to decide hold vs re-buy given it's almost time to make tax decisions

[Donein25]

Why are you throwing numbers like 6 months or a year  around? Read the NR. There are 16 total responders who were either CR or IR at 450 days. Do you really think it will take 6 months or a year to assess their status? Stop. 

[Rumpl3StiltSkin]

I think some people DO NOT like having to cover their short positions...  :-)

[N0taP00p]

Donein:  OK. I re-read.  The only thing gating pre-BTD submission seems to be survival data for those 16 (14+2).  I was confused by the part of the statement that said "... By introducing these optimizations in study 2, future reviews with the regulators will be more efficient..".   I assumed that meant those optimization results are required to complete phase2

[Donein25]

You are probably right; Q1. 

[Eoganacht]

In my opinion this will have no effect on the timeline. But it might improve the chance of attaining a CR for the patients in the trial who have not yet reached 450 days. I don't see why the FDA would change what they are looking for in a BCG-unresponsive NMIBC treatment based on changes Theralase has chosen to make to the protocol of their trial.

[Benedictus]

Agreed. I also view this amendment more in the context of expected commercialization. The exemplary safety profile is underlying this decision to refine the maintenance treatment protocol not just as a means of improving CR data for the study but in terms of refining the inevitable commercial protocol and achieving even better outcomes for patients.  Now we just have to hope with such