Theralase Technologies Inc. V.TLT

It's a bell-curve thing.

[gojotv!]

Theshare price is in a doldrums, and it's a bell-curve thing.
You have some investors who completely get it, and are ravenous for shares, some who don't understand or believe in the tech at all and the majority in the middle...
They want to believe, but don't really "get" the science and doubt that this non-toxic, day-patient, highly effective treatment approach could possibly be true.
It's just too good.
And when you see reports day after day about people rejecting science, you realize why their dollars aren't flowing into TLT stock. But when this becomes THE new standard of care for bladder cancer (and when that happens, it will happen with astounding swiftness) the skepticism will subside and all eyes will be on TLT.
Just visualizing that makes the wait worthwhile.
And no idiotic talk about buyouts, please. What kind of fool sells his gold for a few copper pennies?
The Covid crisis made it clear that Canada needs its own Pharma-tech corporation to put us ahead of this and other crises in the future.
And I, for one, will be happy to collect dividends from my shares well into my old age.
Anyone who doesn't like that idea can sell now, please.

[newdaydawning]

Just to clarify what you said about TLD-1433 becoming standard of care  "with astounding swiftness". My understanding, and I may be wrong, is for TLT's bladder cancer therapy to become standard of care, we would have to succeed in a costly Ph3 trial in a head-to-head contest with BCG. Many here have suggested that in order to progress to Ph3 we will need a deep-pock pharma

[enriquesuave]

if it becomes established that the majority of patients are CR after an optimized treatment, then no need for a PH3  IMO  Drs can eventually use it off label as first line for HG CIS NMIBC.  But yes to replace BCG by standard pathway would be to do a PH3 trial.  For now BCG Unresponsive market is almost as big as about 70% of BCG treated patients eventually relapse and need

[newdaydawning]

Thanks enrique for clarifying my clarification. And yes, there is a huge addressable market after expected Ph2 success.

[gojotv!]

Right now, we're in the application process for "breakthrough " designation. Since TLD-1433 has shown improvement on several endpoints, I fully expect we'll succeed. And after that, this paper confirms that the FDA's focus is on time-saving... which means serious money-savings for TLT. FDA guidelines - "Breakthrough" from the bottom of page 13 on....

[CancerSlayer]

Enriquesuave wrote: "If it becomes established that the majority of patients are CR after an optimized treatment, then no need for a PH3  IMO  Drs can eventually use it off label as first line for HG CIS NMIBC.  But yes to replace BCG by standard pathway would be to do a PH3 trial.  For now BCG Unresponsive market is almost as big as about 70% of BCG treated patients

[socksnblonds642]

Doesn't off label usually refer to using an approved drug for a use other than it is intended for rather than using an unapproved drug for its intended purpose? I'm not sure but's that's how I understood it. Overall doctors go off label 10-20% but yes higher % with children. 

[CancerSlayer]

  You are correct & maybe I wasn't clear.  My statement was made with the assumption TLT got FDA approval based on high efficacy (I.e." 60+%")...though I think we get FDA approval with less based on the approved competition (Keytruda) & general lack of good options.

[CancerSlayer]

  ...."can" get....    Though there's a good chance we achieve higher imo.

[Rumpl3StiltSkin]

Great discussion guys! I am optimistic like Gojo, though I might disagree on which group out there is 'rejecting science', lol. ;-) Regarding BCG as SoC, Isn't it running into some sort of supply constraints? Manufacturing limitations? Also, I thought there was some discussion on here some time ago on a new 'shot' out of the UK, that would eventually make it over here, that is