Theralase Technologies Inc. V.TLT

News Out

[digitalstone]

Man oh Man !  Good news, but pushing the Break Through Designation back again ... really ?
Frustrating!

"Supporting Break Through Designation approval from the FDA in 3Q2024."

[Lesalpes29]

Pre-BTD Q2 and full BTD in Q3? And AA before year end. GL

[Oilminerdeluxe]

I suspect those two cost a bit of money. Sooo, one might suspect good news to be locked in for the next Q or so. One can hope at least..

[enriquesuave]

It was expected end of Q2 beginning of Q3.  I hope it's still first half of Q3 for BTD.

[stocksnbonds458]

I think the best case scenario is to have the FDA's pre-btd questions answered and submitted by sometime in Q3. The actual BTD submission would then likely be sometime Q4, with an answer from the FDA early 2025.  The process is agonizingly long when you don't have deep pockets.

[Infinity]

One would think that the TLT Management would have known about this agonizingly slow processing time for BTD Applications when they made the forecast that BTD a possibility in 1st quarter 2024.  As far as I know, TLT has not even completed the Pre- BTD and obtained guidance to go ahaed with the formal  BTD application.  We all know TLT obtained Fast Track status before COVID hit us.

[managementfirst]

Very fair words---I think frequent changes in Management is the main reason for the lack of continuity.  Dr. Shirazi was doing fine for a few years, folliwed by Dr. Vera Madzarvic, few more on the Device side of the business as well.  Leads me to believe RDW either has a real problem in holding on to skilled and talented people that he hired in the first place or he tends to hire the

[StevenBirch]

When you're ready to sell let me know and I'll hop on the bid.

[Infinity]

Sure thing.  But why wait for me to sell?.  What is stopping you from jumping in now and buy at $0.16.  I don't think it is going to get much lower!!.  If I were in the market to buy TLT I would do it now!!.  Hoping you would take advantage of the low price and build up your stockpile!

[Legit62]

Probably 2nd quarter 2025 from the looks of it, dissapointed another timeline missed but holding shares, too much of a loss to dump now unfortunately

[Infinity]

Agree with you.  Not much is likely to happen before 2nd quarter 2025.  RDW has Dr. Jewett, as a consultant.  Hopefully he is able to speed up enrollment in the clinical trials and increase more study sites..  We have been bogged down at 63 patients for way too long..

[Infinity]

I think they are refering to BTD final Approval from FDA in 3rd Quarter.  I believe, they will apply for PRE BTD this quarter and Formal BTD soon after and get an answer back within 60 Days.  BTD  approval cannot be earlier than 3rd quarter at best.

[Galaxym31]

Day after warrants expire .

[riverrrow]

Management should just come clean and admit they have no idea when they will submit their BTD application.

[Dumbeldorfwhite]

You know it's bad when Mr. Try to spin it river boi is upset.

[TimboBaggins]

and why it's taking so long. Just be honest. If it was a screw up, how big of a screw up? 

[toade1313]

They should hire someone that can wrote press releases on issues shareholders want to hear about - positive or negative. Avoiding the subject leads to shareholder discontent and following SP declines. 

[Dumbeldorfwhite]

Why when you can sue people to keep their mouths shut

[Kayz88]

They pushed it back in Q1 didn't they? They started inching away from the Q2 deadline and now committed to Q3? I don't know anymore...

[Dumbeldorfwhite]

Because like I said years ago, the clinical team doesn't appear to be adequate to handle a trial of this magnitude, which is evident by the sloppiness of the trial (not treating the first 12 correctly, not planning enough money, not having the enrollment expected, not expecting 450 day data) Dont even get me started on the "GLP" studies, if I had to guess they won't get done

[Galaxym31]

Hire some high school science geeks .

[reconsider]

Do you remember when we were told that BTD submission could be "a question of days"? That didn't aged well... If this 2024 I don't see BTD or licensing/partnering agreement I'll be out.  GLTA

[riverrrow]

I had a firm deadline to get out of TLT based on performance or lack thereof a couple of years ago and yet here I am.  GLTA.