Theralase Technologies Inc. V.TLT

TLT Header

[toade1313]

The header here was changed from 72 patients to 75 patients. The estimated enrollment completion stayed at the end of 2024 despite RDW stating in the last PR that was 'possibly into early next year'. Wonder which will turn out to be more accurate?

[Alamir1111]

Theralase PDT Technology Used to Treat First Patient for Bladder Cancer   V.TLT | April 4, 2017

[TommyNickels]

All.depends on what the FDA is willing to accept. I would assume they will want to see at least 75 patients evaluated at 90 days. If so, I think we need just 1 more patient. Get 2 extra. Just in case. 

[Alamir1111]

Those 2 extra patients would be another 5 .6 months delay  ??

[TommyNickels]

3 patients could be treated by end of November.    The patients treated in September would hit 90 days in December. 74 patients + 1 who passed away early. Assuming the data is relayed back to Theralase quickly, could be apart of Break Through Designation.  The last 3 would cross 90 days in spring. This data would get submit to the FDA plus all the other points of data that

[Infinity]

Justification for more Delay?