Theralase Technologies Inc. V.TLT

Keep patient, maybe we are at last step to the final victory

[managementfirst]

If you are the management, you have inside information from regulatory guys knowing only very less more information needed for green light signal, you will just

Keep silent to avoid any trouble, and no inside buying in recent PP.

[riverrrow]

I want to agree wholeheartedly.  Somethings afoot.  When was the last time Roger didn't participate in a private placement?  No insider trading violations for management at TLT.   GLTA.

[Oilminerdeluxe]

Roger not participating was interesting. 

[Alamir1111]

It's  kind of hard on somebody's  bank account to come up with 100's thou $ every 3 months to participate in pp

[DJDawg]

I also find it interesting that the last PP was announced via an email from MP. As if trying to show the most fairminded open offering possible. My friend who has been on the RDW call list for all the other PPs always got a direct phone call from RDW about the previous PP. Whereas this one was done differently. I'd like to be wishful and think that RDW didn't participate in the most

[skys1]

Agree managementfirst about the changing BTD app time lines. I'm certain the FDA wouldn't be too pleased if the Company was giveing out information about on going discussions with the FDA regarding when this or that item is satisfactually approved or has to be supplied to be approved. Keep in mind, that PDC is something relatively new for the FDA and new questions can arise and I'm

[Legit62]

Agree Skyys1, something very different about last PP, no Roger or Kristina buys, no insider buys, something is up, maybe hear soon

[wildbird1]

Skys1...Excellent post. Almost every single time the SP stabilize, someone bring up the same two subjects. 1) Reverse-split, that will never happen, because with multiple cancer treatments on the table(Bladder, Brain, Lungs...etc), over 300Million shares is a puny little number of shares. 2) Transparency. When people can't denigrate the data that are breathtaking, they denigrate management

[N0taP00p]

Wild:  I honestly don't get why it's so hard to understand, unless you thrive in an environment that needs an enemy.   An us vs them to key you up while waiting for deliverance.   Do you realize I own and have owned shares for more than a decade? The difference between some of us and many of you blind cheerleaders is that you have gotten very emotionally attached.&

[plantrader]

Basic psychology. Everyone is hopeful, but the company is at risk of running out of money several times per year at this point, right? Is that debatable? The clinical data that we're aware of is very promising. There are lots of great possibilities. However, nothing seems to happen even remotely close to the timelines the company shoots for. And the info or explanations offered to help

[N0taP00p]

Plantrader:  Thank you for your balanced views.  Yes, being a small company with limited funding creates problems.  They've done a lot with what they were given.  However, keeping shareholders interested (and motivated to keep holding) could use a little more work.  Just tell us where things are at in a more transparent way.  Don't bury delays under NRs that

[plantrader]

N0t, I have to agree. I understand and would theorize that there are much more important issues that we probably aren't aware of. But still, it's not very difficult to be clear is it? And to keep in mind that when you change timelines repeatedly and/or other milestones aren't accomplished for notable periods of time (enrollment?) then naturally most everyone would like to know why

[TimboBaggins]

  Im hoping that they start acting quickly on this quote; "the Company plans to secure funding through various equity and debt instruments to allow the Company the ability to become base shelf eligible" If they've already started the application, I figure maybe 6-12 months until they have millions. There is a small chance it takes 3-6 years with Theralase's track

[Longholder99]

I want to think that the lack of Board member participation in the last financing mixed with 1st time ever outreach by Perraton as noticed by someone else here earlier.  Signals that BTD has been submitted. Insiders knowing this to.be factual would benefit greatly from this insider knowledge so they wisely steered clear.  Its what I want to think and in my world it makes sense. 

[TriumphSpitSix]

Interesting theory. Do we have evidence they also self-imposed a management blackout when they originally submitted BTD application in July 2023? Two PPs closed around that time: June 30, 2023  Sept. 7, 2023 Did RDW or other Director/Manager participate in those?

[Northmen]

Yes - RDW in Sept 23 2023-09-07 Dumoulin-White (Roger John)10% Security Holder of Issuer 424,000 $106,000.00

[Eoganacht]

Theralase did not submit a BTD application in July 2023. What they submitted was a "Preliminary Breakthrough Therapy Designation Advice Request" after filling out a template supplied by the FDA. "This template should then be submitted as a formal amendment to the IND and a subsequent teleconference between the sponsor and the review division will be set-up by the RPM. The review

[Alamir1111]

Break Through Designation Update In 2020, the FDA granted Theralase® Fast Track Designation ("FTD") for Study II. As a Fast Track designee, Theralase® has access to early and frequent communications with the FDA to discuss Theralase®'s development plans and ensure the timely collection of clinical data to support the approval process. The accelerated communication

[TriumphSpitSix]

BTD, Pre-BTD, whatever. I get it, but that's not the point... Does one justify a blackout period and the other doesn't? That's more to the point of the speculation as to why RDW did not participate in the latest PP and other administrative changes to its execution. Was it due to actual, final BTD submission or some other reason that would dictate a management blackout period? Maybe

[Alamir1111]

Will see if rdw participates in next pp.guessing will be at .15 c .21 warrants 

[Eoganacht]

That's right. Any number of reasons could explain it. We're just not in a position to know the correct explanation.

[DJDawg]

Thanks Eog. I've always felt that this is what has been happening and TLT has just been framing it as pre-BTD. Reading up on CGON and others I think one big protocol goof that they did was around bladder biopsies. CGON, which has bladder biopsies (random sampling of a bunch of spots) at 12m if I recall the details. When you have urine negative cytology, confirmed by a central lab, rather than

[Eoganacht]

Hi DJDawg. That makes sense. The further out data request may have been to firm up Ruvidar PDT's CRR data. It may. also have been for the purpose of comparing longer term durable response with competitive treatments that already had the collection of data for 2 or 3 years as part of their protocol. During the conference with the FDA, Theralase may have been advised that a definitively better

[Alamir1111]

https://stockhouse.com/news/press-releases/2024/05/02/theralase-r-expands-clinical-team So my hunch is that the following happened 1. Preliminary Breakthrough Therapy Designation Advice Request was held and the advisor didn't say NO or YES but rather, maybe but you need more information (central lab and further out data) to compensate for lack of biopsies and to just be more confident

[Alamir1111]

https://stockhouse.com/news/press-releases/2023/05/24/theralase-r-appoints-roger-dumoulin-white-as-president-and-chief-executivehttps://stockhouse.com/news/press-releases/2023/06/06/theralase-r-announces-appointment-of-new-independent-directorhttps://stockhouse.com/news/press-releases/2024/02/08/dr-michael-jewett-joins-theralase-r-to-help-complete-enrollment-in-the-phase-iihttps://stockhouse.com

[Alamir1111]

Did any of you apply for a nexus card to us ? What would be the offences to get denied?

[Legit62]

Shorting TLTFF

[Alamir1111]

2024, the Company plans to secure funding through various equity and debt instruments to allow the Company the ability to become base shelf eligible. This will allow the Company sufficient funding to complete enrollment into Study II by year end, data lock in mid 2026 and position the Company for FDA and Health Canada approval the end of 2026."

[Alamir1111]

Kind of like Martha Stewart  is a co signer

[Alamir1111]

Matthew Perraton, PFP, FMA, FCSI, Pro. Dir., Chairman of the Board of Theralase®, stated, "We are thrilled to welcome an individual of this caliber to our Board. Dr. Lbiati possesses a wealth of international experience across all aspects of drug development, from: clinical research to medical affairs, marketing to commercialization of various drug candidates. Her expertise comes at

[stocksnbonds458]

For goodness sake people, why waste your time creating these complicated and quite frankly incorrect theories about why it has taken so long to reply to the FDA's Pre-BTD questions? Why not just call Roger and ask? If you did, the need to fabricate convoluted reasons for the delay may evaporate! Or is that to simple a solution, and its more fun to make stuff up?

[Infinity]

This stock has been underperforming for years for no apparent reason.  We have stellar clinical test results as  reported by the management.  The company has been struggling to raise capital as we have seen the past PP's.  Few remaining faithful investors are simply being cautious by staying away or coming up with smaller amounts just to keep TLT afloat.  PP's

[chry200030]

So, please tell us........... why are you here ???????

[Infinity]

Trying to be realistic and not join the Pumping that is going on here.  Plus the odd Chuckle perhaps..

[N0taP00p]

"...Keep in mind, that PDC is something relatively new for the FDA ..".   Ever heard of Photofrin?  Just in case facts and DD matter. 

[skys1]

Poop - I didn't say none.  I said "relatively new".  In case you don't realize it, that means there have been a few. "Just in case Facts & DD matter".

[N0taP00p]

Skys: Touche.  My sarcasm wasn't warranted. Apologies.