Theralase Technologies Inc. V.TLT

Patients who remained in Study 2

[enriquesuave]

This quote seems to indicate that most probably initial12 not counted after 90 days.  They started off in trial, ( hence included initially then dropped) and since were undertreated are now dropped after 90 days. IMHO 


"The interim clinical data demonstrates a 90 days CR of 54% (n=52) and a sustained duration of response at 450 days of 67% (n=12), for patients who remained in Study II.

Note: To be included in the statistical clinical analysis a patient must be enrolled in Study II, provided the primary Study Treatment

 and evaluated by a Principal Investigator (“PI”) at the 90 day assessment visit (cystoscopy and urine cytology)"
We will eventually get more details, but this must be in line with Statistician they are working with and FDA.  Haven't yet called company.

[N0taP00p]

I would hope they provide two sets of data one with the 12 included one without. Letter of the law versus spirit of the law,  considering there are bladders at stake. I would also hope they hit the submit button by the time Q1 results are announced in May. 

[Eoganacht]

The phrase "...patients who remained in Study II" is ambiguous. It could be referring to the exclusion of the first 12 undertreated patients or it could also mean that the patients who developed high grade NMIBC are no longer being evaluated at later time periods. It would certainly be to our advantage if the first is meant and the FDA is allowing the 12 undertreated patients to be

[wildbird1]

Eoganacht..."patients who  remain" could simply refer to the fact that some patients have been removed from study11, as stipulated in the 2Q2020 Newsletter, were TLT said 4/12 undertreated patients were removed from study11.

[enriquesuave]

Yes Eoganacht.  I would think that even NR patients with progression would be counted as evaluable, and as NR.  It clearly states 8 out of 12 evaluable patients are CR, 2 IR and 2 NR.  With more clarification this will be made clear.

[Eoganacht]

I very much hope yours is the correct interpretation Enrique. If it is we could be looking at that 50% - 60% complete durable response.

[Eoganacht]

Just one more senior moment. I meant to write - 40% - 50% complete durable response.