Theralase Technologies Inc. V.TLT

Accelerated FDA Approval

[enriquesuave]

One way to look at it is:  Would the FDA give full approval if the trial was complete today with 28% CR at 450 days and 10% IR after 110 patients treated?  I strongly believe it would be a yes, given that that would be better than Adstiladrin and only 2 safer treatments.  All IMHO.  Now that 1/2 trial is done if data trends even higher with optimized treatment, then it will be clear that we will end up with 28% plus CRand well above already approved Adstiladrin.  So next AUA data presentation and data point may be the final drop needed to get AA.  Just maybe.  All IMHO

[N0taP00p]

Your humble opinions are always good, Enrique.  Let's hope they stick to submission in Q4 or Q1 and get BTD now, and like you say, maybe AA soon after. 

[Infinity]

I agree Enriquesuave..  The clinical test results are great.  Projected to be more effective than Keytruda is really impressive.  Some kind of MD and A from our CEO or RDW into their plans for a JV would be a nice touch.  Even if they are pre-liminary discussions with FDA on their BTD application would propel some action in the stock price.  Reports from Analysts like Dr