Theralase Technologies Inc. V.TLT

Confirmation...

[Yajne]

That an FTA application has been formally submitted, also the actual date of that submission was not provided. They must feel that results were 'good enough' to make an attempt for FTA

"Based on this guidance, Theralase® has submitted an application to the FDA for FTA and is currently awaiting their response"

[Quattro74]

They will, I hope, be waiting until their actual % numbers from Phase 2 are better, which will give them a good chance of getting FT. 

[Yajne]

Their statement in the quarterly clearly says they have already submitted the application. So the FDA clock must already be ticking

[Quattro74]

Hmm, yeah I see your point. So is the official % CR from Phase 2 43%? I mean that isn't the final % number but is that how it sits now? I wonder if the FDA will be satisfied by that? Or will they look forward at what is likely to happen?

[baystock1]

The below quote from the newsletter implies that the basis for the Fast Track Approval application is the phase 1b results: In a 3Q2019 conference call with the FDA, it was discussed between the FDA and the Company, that the Company would potentially be eligible for Fast Track Approval (“FTA”) post receipt of the FDA IND authorization, based on the clinical study data