Theralase Technologies Inc. V.TLT

to launch 4 to 5 clinical study sites in USA 4Q2020

[floatinketucky]

Theralase® is in advanced discussions to launch a number of U.S. based clinical study sites in 4Q2020, subject to the United States economy recovering from the COVID-19 pandemic. The U.S. based Trial Management Organization (“TMO”) plans to launch 4 to 5 clinical study sites in 4Q2020 and commence Study II patient enrollment and treatment as early as 1Q2021

3Q2020  QUARTERLY NEWSLETTER

[Macer]

Would love to see this happen, but the COVID crapstorm in the US may prevent this from happening on schedule. TLT needs the US sites to stay on track with timelines Macer

[floatinketucky]

Clearly the FDA is accepting Data points on Canadian patients. We could see the bulk of patients treated in Canada. Perhaps we should expect this. 

[floatinketucky]

  Further in the midst of the covid spike the FDA found the time to review data and approve the Fast Track Designation for Theralse's  Phase II NMIBC study.   So the Covid consideration was not sufficent to stop a good decision by the FDA. The US hospitals likewise, may very well like to continue the good decisions.  The pressure to also treat other deadly

[skier59]

Yup I've said this before, the FDA can grant approval of a drug if it's study and subsequent approval is achieved in another country such as Canada. We actually don't need, although would only be a positive, study conducted in the USA. But, as I've said, let's not let this COVID situation slow us down anymore and get that 24 bottled up in Canada ASAP.