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To: Underexposed who wrote (1412)11/8/2019 6:33:30 PM
From: ogi
   of 1639
 
I am incapable of fully appreciating your TA efforts. That does not mean I am not glad of them and that I still do get a benefit from them.

I think we are on the same page:

""But things are neutral bearish right now ""

Tlt is behaving exactly as it has in the past, so to your point, I am pretty sure Roger and CFO wife are still well in command.

The fact TLT's 2000 series lasers have been recalled by Health Canada and not a word said by the company just reeks. Pretty hard not to draw a connection between that fact and the departure of the new CEO of devices division.

I am fully convinced of the PDC technology, its promise and the strength of intellect behind it. The quality of the TLT medical personnel is superior, far different than "devices" . As am engineer, I expect RDW must be more deferential to the oncology division than to that of the devices. That said, it is hard to believe recruitment is so slow in Canada , while the U.S. sites have not been brought onboard yet.

Believe me , one of the most important DD criteria on any junior is the timing, price and terms of any private placements. Those terms indicate the quality of management. On that basis TLT is an exceptionally bad fund raiser and by extension an exceptionally bad management, new CEO has shown no positive impact to date.

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To: ogi who wrote (1413)11/8/2019 10:23:08 PM
From: Underexposed
   of 1639
 
The fact TLT's 2000 series lasers have been recalled by Health Canada and not a word said by the company just reeks. Pretty hard not to draw a connection between that fact and the departure of the new CEO of devices division.

Yeah, you are probably right...in reading the recall by health Canada it looks like a cluster-F for delivery. They have been making that TLC-2000 for years.... has this been a problem all along or did they jump the gun .... hard to say.

I don't think this affects the Phase II study at all as a different laser is being used.
That said, it is hard to believe recruitment is so slow in Canada , while the U.S. sites have not been brought onboard yet.
It is not unlike last time.... they have a very specific criteria that has to be met. I am encouraged that they at least have one candidate as of September and that Patient 6 and 5 are cancer free still.

I think they have an order to this trial... first Canadian sites.... 3 selected now.... then USA.... then Europe.

It is my guess they want to make any mistakes in this phase in Canada rather than shotgun it out immediately .... that is my guess anyway.

UE

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To: Underexposed who wrote (1414)11/9/2019 3:07:46 AM
From: 3bar
   of 1639
 
This is correct " I don't think this affects the Phase II study at all as a different laser is being used. "

2 separate systems the recall has no effect on the Phase 11 trial . This was verified by a phone call .

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To: Underexposed who wrote (1414)11/11/2019 8:00:26 AM
From: ogi
   of 1639
 
Yes, I understand the recall is independent of the trial. But as you say a Cluster F and one that in my view must be closely related to the departure of the device division CEO. Ie is all well at head office? It is simply another incident that does not inspire confidence in a management that has already been sanctioned by the OSC. I think the medical division science is so complex, requires very specific skill sets and has such incredibly good scientists on board it is harder for bad management to interfere.

Tlt has stated Europe has been dropped in favour of just Canada and U.S..

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.

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To: ogi who wrote (1416)11/11/2019 11:33:09 AM
From: Underexposed
1 Recommendation   of 1639
 
Yes, I understand the recall is independent of the trial. But as you say a Cluster F and one that in my view must be closely related to the departure of the device division CEO.

The exit of the device division CEO is obviously due to that recall. The device division predates the anti-cancer division by years.
Here is evidence of why the recall was made.



In the red circle you see the offending certification label
CE stands for Conformité Européenne (French), which means European conformity.
CE marking is a self-declaration where a manufacturer proves compliance with EU health, safety and environmental protection legislation and confirms a product's compliance with relevant requirements.

Now I think this is a requirement since 2015... and this is necessary to sell their lasers in Europe. My guess here is that the TLT lasers predate 2015 so TLT probably did not apply for this label or ignored it all together.

As a former instrument sales man in my working life.... If I was a European representative I would have been hounding TLT to get this certification....which should have been a rubber stamp unless the regulations were different from the past...even then I doubt it would have taken more than a year to get.

this is the explanation of the labels shown in that picture above.



So....the red circled item here is information of their European rep.... the outfit who should have been badgering TLT for that CE certification... It is not an approval rating.

EC....CE.... potatoe/potahtoe.... Either the CEO told his staff to add the CE label and the EC explanation in the manual or at the very least approved it.

Either way he had no idea what he was doing and should have been fired IMHO.... Not only him but the staff member who did not have his back and warned him of the problem... Maybe the CEO was bossy and the staff did not like him so they let this slide to get rid of him.

The NEW CEO should address this problem immediately.... As I said ....this was a Cluster-F.

UE

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To: ogi who wrote (1416)11/11/2019 12:06:02 PM
From: Underexposed
   of 1639
 
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 1639
 
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 1639
 
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 1639
 
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 1639
 
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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