Theralase Technologies Inc. V.TLT

Potential Rise

[enriquesuave]

I remember about 4 years ago when SESN bio went from 0.60 to over $3 ( from February to May a gradual increase) in anticipation of preliminary 90 days data readout on about 55 patients.  The anticipation was to see if doubling the number of treatments from 1 per week to 2 instillations per week would increase efficacy seen in PH2 of 40% at 90 days.  It didn't and no increase in efficacy was noted, and SP went down gradually to around $1.  Can we see the same happen here but go even higher on favourable data?

[enriquesuave]

To be specific that preliminary data that SESN bio had presented was at the annual  AUA meeting in May, the same one where our data will be presented on a moderated poster session.  The visibility will definitely be greatly increased.  

[ScienceFirst]

EnriqueSuave ... You think that adding up to 9 new sites would be to validate a cohort of patients receiving let's say 4 doses, instead of just the actual 2 ones?  If so, that would be interesting and could only come on a FDA guidance/suggestion.  If so, that would be excellent. I'd be very interesting to first see the efficacy %s of the optimized group (p#13-25) as my numbers

[enriquesuave]

Anything is possible, but the good thing is that right after BTD, the FDA will give them guidance on possible AA and timeline may be established at that time.  Definitely interesting times ahead.  

[consultant99]

Interesting point raised about more than 2 treatments.  I have wondered if any patients so far that were NR after their first treatment achieved PR or CR after a second treatment. If not is this a limitation for the technology  I also wonder why after 450 days the CR rate drops below the 90 day level even though patients that did achieve CR go through a second treatment.  I

[fredgoodwinson]

Good questions consultant - hopefully some enlightenment on the 17th.

[N0taP00p]

That's the million dollar question. What was the result of the post-PR analysis. How many have made it into the CR bucket within FDA guidelines

[Eoganacht]

Hi consultant99 - with all of the BCG-unresponsive NMIBC treatments we have been talking about on this board the initial CR rate declines over time. But there is more going on with our trial that further explains the CR drop at 450 days. Of our 43 evaluable patients at 90 days 53% exhibited a complete response. The 12 initially undertreated patients represent 23% of these 43 evaluable patients.

[enriquesuave]

Well stated.  As well I think we can really count 14 or at least 13 invalid patients from 1st set of 29.  As 12 were severely undertreated, but afterwards 1 patient who died of HF was counted as NR, and 1 of the 3 patients from PH1 was also not given an optimized treatment and was probably invalid due to metastatic disease unrelated to bladder.  All IMO, so 13 or 14 out of 29

[Eoganacht]

As a thought experiment, if we assume 12 of the 14 questionable patients were not CR or IR and we remove them from consideration at 450 days, we are left with 8 CRs out of 17 evaluable patients or 47% at 450 days. Further, if the 3 IR patients at 450 days are recalculated as CR  we would have a 450 day CR rate of 65% - which, (admittedly coincidentally) is the same as the phase 1 results ( 63

[N0taP00p]

I did own SESN for a while and then sold. May have a few hundred still left.  In TLTs case, the anticipation will be AA after BTD, so hoping any spike will sustain itself. Curious to see what happens with IBRX. Their next decision from the FDA is expected around May, I think. 

[enriquesuave]

It might not be for nothing that the FDA is going for standard review time for IBRX rather than priority review?  Although they got BTD which normally means priority review.  Perhaps they are waiting to see TLD-1433 data to decide if a combination trial drug needs to be even higher efficacy than best single drug?  I'dont know, but if a single agent produces the same results as a

[enriquesuave]

Priority review would have been 6 months instead of 9 months, obliging the FDA to give a response now in February Vs in May?