Theralase Technologies Inc. V.TLT

Are we halted ?

[maxonfire]

I wish we were !

[ramrodretired]

Yes, Strange this time aday and NO volume! GOOD OR BAD?

[Legit62]

I put buy order  in wouldnt take

[chry200030]

We are just waiting on FDA approval news now.  Then we balst off.  How long? a week, a month or 6 months., but it will come.

[wearethebest]

Yes and if this was a US company it would already would have FDA approval.This is something that could save a lot of peoples lives and this is stupit  on their part don't you think.

[fredgoodwinson]

Agree WATB that this would have had approval by now if it were a US Company - probably some time ago (and first line in an early stage setting - a far bigger market). Whether this represents stupidity on their part is another matter. 

[ScienceFirst]

What type of reasoning is this??? FDA approvals have to be based on data.  Not on air.   It happends that we just reached 1.5 months ago the milestone (450-days data on 25 patients) that was requested by the FDA at the time of the design of the Ph. 2 trial.  And that was for the BCG-Unresponsive market. The same that want rigor are the ones that want to skip steps because

[fredgoodwinson]

This reasoning is in the context of a belief (which I strongly expressed at the time of the Clinical Protocol) that on the basis of the preclinical evidence TLD-1433 deserved to be trialled as a first-line treatment against early stage disease. Many lesser prospects had and have been permitted this setting.

[gebremeskel]

Your belief about how TLD-1433 "deserved" to be trialled is beside the point. Did Theralase request this of the FDA and were not "permitted"? Or did Theralase submit the exact protocol they wanted to - for BCG-unresponsive NMIBC? 

[enriquesuave]

1st line would require a head to head trial of about 500 patients vs BCG in a randomized control trial. IMO. Much more lengthy and costly.  Now we can potentially be used off label as a 1st line treatment, as well as for unresponsive BCG when hopefully approved.  IMHO 

[fredgoodwinson]

If Enrique is correct as to the likely number of triallists required then accept that first-line/early stage would not have been feasible on the grounds of cost unless partnered.

[ScienceFirst]

Wrong, unless you can provide real examples. It is not the way drug approvals have ever worked (starting from early staging).  It has always been the opposite, for obvious reasons, as drugs that have never been tested could represent a risk. The FDA, with its FrontRunner program, wants to accelerate the venue of late-stage drugs faster to early stage.  But once again, these drugs must

[Rumpl3StiltSkin]

So SF, At this point is it likely, or even possible, that TLT has applied for BTD. Or are we still likely waiting on clinicians to crunch the CR data on these first 25?

[ScienceFirst]

Rump ... Very difficult to call.  It all depends on how many people are involved in the process.  

[enriquesuave]

My guess is that if Dr Kulkarni who is the principal Investigator is presenting data mid February, then for sure by then we should have all stats needed for both  FDA and Poster presentation.  At least IMHO.    

[ScienceFirst]

Enrique ... After looking at the abstract conditions last night, there are some things that cannot be included.  Like efficacy %s, for example.  It's really regulated. Please refer to my post of yesterday, 01:04pm. Soon after Feb., we might be able to see what might look like this poster, if no ASCO rules prohibit that.

[gebremeskel]

Sorry, that doesn't make any sense. Whether you're from Timbuctu or the good ol' USA, before you can get FDA approval you need to submit a minimum amount of clinical data as evidence of safety and efficacy. We haven't done that until just now! As my old pal Charlie Drake once sang, "If you want your boomerang to come back, well, first you've got to throw it!"

[Oilminerdeluxe]

I suspect volume will be a bit different then...

[Rumpl3StiltSkin]

Strange

[Kingpin68]

My small order was confirmed by my bank. Hasn't changed he volume from zero yet though.

[O12009]

No shares has traded on TSX but 28 thousand has traded on the other exchanges.

[RetiredREX]

Any idea how to confirm whether halted or not?

[StevenBirch]

Almost always when a stock is halted the bid and ask will be the same unless it's a stock with literally no activity. And I think we are stuck here until the next release because if the sell-off was PP related there has to be enough of a spread to make it worth it to sell, looks like $0.30 was the lowest, and no one will bid it up just to have the same people come in and knock it down again

[stocksnbonds458]

A lot of my small caps are not showing trading today, a glitch??