Theralase Technologies Inc. V.TLT

Uncharted Territory...

[wildbird1]

I stongly beleive that TLT-Ruvidar BTD approval is being held-back by the fact that having a new PDC treatment halfway through a FDA phase11 trial is a first for the FDA.
The FDA is almost in uncharted Territory(that could explain the FDA asking for more data and clarifications).

I also beleive that the FDA is working hard with TLT to advance this new TLT-Ruvidar treatment.
Why?
Because the FDA gave TLT FTD(Fast Track Designation).
FTD is for unmet medical needs.
The unmet medical need is that no other FDA approved treatments for NMIBC, treat the same difficults type of patients as TLT-Ruvidar(older and heavily pre-treated patients), and is 100% safe.

In short the FDA badly need TLT-Ruvidar.
The fact that the FDA badly need TLT-Ruvidar doesn't mean that the FDA is going to skip a few steps in its BTD safety evaluation protocol, just to give TLT-Ruvidar BTD approval.
No! It doesn't matter how good TLT-Ruvidar CR data are, TLT-Ruvidar has to follow the FDA BTD evaluation protocol.
In short...If a company(TLT) comes up to the FDA with a new and advanced way to treat cancer, this company(TLT) better be ready to answer tough questions from the FDA.

Note 1):
TLT-Ruvidar ignored buy the market???
The market is very concervative, the market doesn't bet on products from small cap company that have not been proven, BTD approval will rectify that situation.

Note 2):
Financing.
The goal is to get enough money to get BTD approval.
How close TLT is to get BTD approval?
To answer that question, we only have some pionters.

-In the May 30,2024 Pressrelease... TLT has commenced to receive the data that the FDA need  for the Pre-BTD approval, and the data received are positive with some patients being cancer free for up to 3 years.
-Lately R.Dumoulin must have received more of the remaining data, and the data must also be positive, that could explain why R.Dumoulin said '' We are close to realizing it's value'' ('' Value'' could mean BTD approval).

For now we wait for the remaining data, it is not like these data were years away.
The data have commenced to come in one month ago, the rest of the data could be just a few weeks away(or lesss).

Can you smell Pre-BTD and BTD approval.

[wildbird1]

Complementary Note: The FDA time-line for the approval of a drug is 12-15 years after the completion of animal toxicity tests. TLT animal toxicity tests were completed in 2014, and 12-15 years is for a drug with a MOA(Mechanism Of Action) that the FDA has seen before. TLT New PDC compound has a MOA(Mechanism Of Action) that the FDA has never before evaluated in a phase11 trial. For a completely

[Longholder99]

Well said Wildbird. So many armchair quarterbacks here love to criticize.   PDC is clearly the future of cancer treatment.  High side effect life limiting immuno drugs and chemo will fade into history.  The only reason TLT is mixing Ruvidar with current drugs is to forge a partnership imo.   

[Alamir1111]

Just a reminder PDC patient expiring 2034 Looking at Roger and  Mandel retirmant is not that far away

[Alamir1111]

Patent  retirement   

[Kayz88]

During the meeting they mentioned that they can extend their patents to 2038. I really wish they'd release their conference notes so I can double check. 

[N0taP00p]

This post has been removed in accordance with Community Policy

[menoalittle]

If they bring in $5 mill (or more), I'd be more than happy to pay up (probably to 25 cents) and take another whack or two of it...

[N0taP00p]

@menoaliitle: I took a whack at it last week to the tune of several thousand shares, twice.  Getting used to the whacks, they hurt kinda late. Let's see what happens early next week.  No news means no pre-determined backer to fill the lofty PP ask.

[plantrader]

Notapoop, Be careful or the insults might start coming your way. Being objective about ALL possibilities, some of which are unpleasant, is frowned upon here by some folks. This, despite the perpetual non-return to shareholders. But as you said, the potential seems too good to ignore. Would be nice if a lot more people (or firms) felt that way though instead of us on a bullboard echo chamber. Can

[N0taP00p]

@Plan: The insults are understandable. Par for the course.  As for RDW doing promotions, he's constrained by a lack of visibility (perennial penny stock on a small Canadian exchange, PDTs are not mainstream, etc). He's doing what he can in his restricted orbit. If they do get BTD, lot more opportunities to promote. Let's hope they get the money they need for another quarter or two

[gebremeskel]

LOL One of the least informed and unfailingly negative posters is afraid he will be insulted because of his objectivity! You can't make this stuff up! 

[N0taP00p]

Pretty wild. My comment saying there are many armchair quarterbacks who have been talking about imminent success for a dozen years and also saying I don't expect anything different next week has been removed over "community policy". Go figure.  Hiding from the situation doesn't change the situation, does it now?  Common sense. 

[Galaxym31]

Rome was not built in a day . I need to wear shades .

[DeathXray33]

My personal opinion is no deals. Why mess with that when you can buy & own all the patents, do what you want with them and have the power of god in your hand. Hail 1466...