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To: ogi who wrote (1416)11/11/2019 12:06:02 PM
From: Underexposed
   of 1576
 
TLT has stated Europe has been dropped in favour of just Canada and U.S..

I have not found a statement to what you said.... I have seen that Europe is last on the list to do testing.

Personally, as I have said in my past post, in my working life I was salesman for scientific instrumentation for Occupational Health and Safety (I did not say the last bit before) for over 15 years.

FDA approval is quite powerful but following a FDA approval protocol in Europe for testing probably does not carry any more weight to just getting that FDA approval in the USA. Europe probably has their own approval agency with probably a slightly different approval protocol. That and the fact that they don't have that CE certification on their equipment would slow them down.

I doubt that TLT dropped Europe as such.... they have enough on their plate with just getting the FDA Phase 2 approval which from what I have read could take up to 2 years to get.

the first step was getting the FDA Investigational New Drug (IND) Application approved. Now they applied for it on Oct 1/19 and FDA had 30 days to disapprove it if they see a problem with the application.

Well apparently there is no notice of disapproval after almost 8 weeks so I assume all is clear to go ahead with getting American sites for testing. Don't forget that TLT already discussed the testing protocol with FDA back in June... so this IND is just a formality IMHO.

So now begins the process of acquiring USA test sites which takes time.... look at how long it has taken to sign up 3 Canadian sites with more of those to come.

We just have to be patient.... After Phase 2 approval there is still Phases 3 and 4 to pass....

The sooner the U.S. gets underway the sooner TLT has access to 10x the possible trial participants and the more TLT becomes attractive to U.S. investors.
The sooner the U.S. gets underway the sooner TLT has access to 10x the possible trial participants and the more TLT becomes attractive to U.S. investors.

I too continue to be encouraged by Phase 1 trial results and can only imagine phase 2 trial will have minor procedural improvements that will benefit the process and we shall see if the double dose also improves results.

Agreed on all counts... the Science is what drives me... I like it and have held on for 4 years now with no return so far

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To: Underexposed who wrote (1418)11/11/2019 4:34:41 PM
From: ogi
   of 1576
 
I am time constrained, appreciate your thoughtful responses. Thought I might have imagined or mistakenly attributed another biotech on the point of European trials. But I did get that right: July 29 news.

Shawn Shirazi, PhD, chief executive officer -- drug division, Theralase, stated that: "The enrolment of the first patient at UHN represents a major milestone for Theralase. I am pleased that the phase II ACT-NMIBC clinical study has enrolled and will be treating its first patient. Our primary focus has been to on board sites in Canada followed by the U.S. and Europe; however, as we have been successful in signing an agreement with a trial management organization (TMO) in the U.S., we no longer will be proceeding with European study site on boarding at this time. The addition of the TMO has increased the anticipated number of U.S. clinical sites, thereby negating the need to open up European sites and ultimately a significant cost savings for the company."

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To: Underexposed who wrote (1417)11/11/2019 5:05:08 PM
From: ogi
   of 1576
 
The ce label was just one of multiple issues identified by Health Canada in its recall of TLT lasers.

The CEO had only joined in February and then come September the lead device is tied up in recalls . Previously the CEO of TLT Roger D-White was sanctioned by the OSC for proclaiming the 200 laser biofeedback system was "approved" when it was not.

healthycanadians.gc.ca

So today, with a CEO of the device who inherited that mess resigns after 6 months and the recall of the products , I suggest that product and its regulatory deficiencies may actually represent previous management and so we must consider the possibility the new device CEO quit because the situation is indeed a cluster F. and not the company he signed on to.

Of course I/WE cannot and probably never will know the actual story.

Feb 2018

"""(b) that certain of the Company’s disclosure may have conveyed that the regulatory approvals obtained with respect to the TLC-2000 extended to the"""

theralase.com

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To: ogi who wrote (1419)11/11/2019 8:45:33 PM
From: Underexposed
   of 1576
 
Hi Ogi

Ahhhh, I see it now.

I am time constrained, appreciate your thoughtful responses. Thought I might have imagined or mistakenly attributed another biotech on the point of European trials. But I did get that right: July 29 news.
Here is the thing.... As I said, I have been a salesman and later a sales manager of scientific instruments for 15 years (that was 30 years ago but times haven't changed much.

American and Canadian approvals don't differ too much. We use the same electricity and basically follow similar practices for labour. Europe marches to a different drum. The use 220v not 110v and have different electric codes. I would imagine their safety codes are different as well, certainly their drug approvals are different than ours in north America. Some are more stringent some are less so.

This has always been a difficulty in adopting European instrumentation in Canada and the USA. For a company like Siemens for example .... the largest instrumentation process control company in the world... all of their equipment has Canadian and American approvals because the European approvals just did not stand up to our requirements here.... and vica versa. I represented Siemens competition for a short time in Canada, Hartman &Braun, and I had no end of difficulty when they did not have our approvals.

So, for Shirazi to say TLT is dropping going to Europe for now. I frankly applaud that obvious decision. Why? For 2 reasons:

1. He probably would have to meet different criteria to get a European approval
2. He does not have the qualified people to run a European operation.

That does not mean that Europe is forgotten. Do you think that Europe will ignore the success of the TLT's cure for bladder cancer if we get the results that we are all hoping for??? Nopes, they will be clamouring for our procedure.

Success in the Canada/USA means everything and they should be focusing their efforts in North America first.

Instead of being ho-hum about TLT's decision to let Europe slide for now....we should be happy about it. It would have spread TLT's resources too thin IMHO.

After all, we don't want a repeat of that blunder of the devices group just because poorly qualified people are running with the ball....right!

UE

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To: Underexposed who wrote (1421)11/12/2019 10:04:24 AM
From: ogi
   of 1576
 
I am absolutely happy TLT is concentrating on the N.A. market which will be huge $$ potential. Spend money wisely not widely!! Once HC and FDA have approved the PDT here there will be ways to fast track European approval or that could become the work of whoever takes TLT over.We don't need Europe at the moment.

The recall is strictly the therapeutic relief laser for Canada and is not related to the clinical trials.

Cheers

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To: Underexposed who wrote (1421)11/12/2019 11:52:19 AM
From: 3bar
   of 1576
 
Un thanks for lending your unique expertise to the background on this . The devise division could be very profitable in the long run .

Do you think they would split the company over this or stay the coarse as one ?

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To: 3bar who wrote (1423)11/12/2019 12:54:21 PM
From: Underexposed
   of 1576
 
Do you think they would split the company over this or stay the coarse as one ?

Physically they are already split up. Their anti-cancer research is conducted by experts in various notable hospitals different from the devices group. I believe. The two are integrated through the use of the laser in the treatment.

Unless there is blowback from these "devices" problems that affect the anti-cancer group I don't see a reason to split up. But then I don't know much about the internals of the company to really offer an opinion on that.

UE

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To: ogi who wrote (1422)11/12/2019 12:55:13 PM
From: Underexposed
   of 1576
 
Agreed

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To: ogi who wrote (1422)11/12/2019 2:32:20 PM
From: 3bar
   of 1576
 
Twiter from 8th Nov . Sounds promising/positive . stockhouse.com

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To: 3bar who wrote (1426)11/12/2019 2:55:14 PM
From: ogi
1 Recommendation   of 1576
 
Nice to see it is not a paid for article. Short and sweet but does not miss much.

Here is the actual magazine link.
healthcareimc.com

TLT behaving like some news on the horizon. Time to crawl out of the basement hopefully.

OOOOPS !! I read " about us" which gave no indication the publication was there for company promotion.

The TLT article is by TLT, glad they got it right :)

All posts by Shushu Feng
Public Relations/Investor Relations Coordinator for Theralase Technologies Inc

Articles
Canadian Clinical Stage Biopharmaceutical Company Advances New Cancer Treatment
November 8, 2019 Shushu Feng

A Toronto based clinical-stage biopharmaceutical company is quickly advancing on what may prove to be one of the safest and most effective cancer treatments ever developed. Theralase Technologies Inc. (“Theralase”) is conducting a pivotal Phase II clinical study, with a primary objective of efficacy, of a cutting-edge anti-cancer treatment that utilizes laser light activated anti-cancer … Continue reading Canadian Clinical Stage Biopharmaceutical Company Advances New Cancer Treatment ?


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