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Microcap & Penny Stocks : TLT.v -- Ignore unavailable to you. Want to Upgrade?


To: ogi who wrote (1416)11/11/2019 11:33:09 AM
From: Underexposed1 Recommendation

Recommended By
3bar

  Read Replies (1) | Respond to of 1641
 
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



To: ogi who wrote (1416)11/11/2019 12:06:02 PM
From: Underexposed  Read Replies (1) | Respond to of 1641
 
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