Theralase Technologies Inc. V.TLT

BTD Approval Request...???

[wildbird1]

On the FDA site about Fast Track & BTD...
-Fast Track designation is intended to facilitate the development and expedite the review of drugs(treatments) to treat serious conditions and fill an unmet medical need (like BCG-Unresponsive NMIBC).
-BTD is intended to expedite the development of drugs(treatments) for serious or life threatening conditions. BTD require Preliminary Clinical Evidences that demonstrate the drug may have subtantial improvement over available therapy. 

The big word is Expedite= Make it happen sooner or accomplished more quickly.

Here is a very brief summary of what the FDA want to know before granting a BTD expedited approval request.
The FDA want to know , if the Preliminary Clinical Data to date can predict that at the end of the Phase 11 Trial, the primary,secondary and tertiary Study 11 objectives will have been achieved?

In the last News Letter, Dr.Madzarevic said "In conclusion, it is encouraging to see, from the Preliminary Clinical Data that the company has accumulated to date, that if the trends continue, then TLT is on track to achieving the Primary, Secondary and Tertiary Study 11 objectives.

Dr.Mandel said" I am encouraged by the clinical results to date, which demonstrate the potential to fill an Unmet need for patients diagnosed with BCG-Unresponsive NMIBC".


Is it just me? Or did Dr.Madzarevic & Dr.Mandel hinted that TLT could have accumulated enough Preliminary Clinical evidenses, that would justify an expedited BTD approval request.

Interesting time ahead.

[Rumpl3StiltSkin]

I think it is clear TLT is getting closer to having that BTD. The data should support it within the next several months, 6 at the outside.

[enriquesuave]

Very possible.  Data has improved overall as more and more patients have been treated.   In the Optimized group, we have 60% CR and 20% PR of evaluable patients.  (Vs In the non optimized 12 we had 25% CR at 90 days. )That's a total of up to 80% CR at 90 days if all PR patients would convert to CR.  That would be double that of Keytruda.  IMO.  For a clear picture

[socksnblonds642]

I don't know that the timeline to BTD is that far away. The wording that was used suggested that an interim analysis could be done when 20 were successfully treated. Is that interim on the way to 100 patients or interim of the 360 CR timeline? Safety is still very hi and efficacy seems to be even higher when you look at optimized. The risk is low since it's safe. These patients are looking

[enriquesuave]

Don't get me wrong. BTD can come out any day for all I know. No need to wait for 1 year data IMO just strong 80 day data could do IMO. Approval will need more data at 1 year. 

[socksnblonds642]

Yep approval is a separate concern. I agree the wildbird, I think they've let the cat out of the bag, Lookout wb1!,

[Oilminerdeluxe]

BTD would be great of course, but didn't the company itself say end of 2022 for that? And last time I looked, TLT is not very good at keeping the timelines, he he. But you never now. Perhaps it will happen sooner. Would be a milestone. So, when might the next update come? Anoher 3 months from the recent update? Hope it is not longer, ugh. The numbers could/should turn more positive then. Once

[ScienceFirst]

WildBird1 ...  Great post.  TLT news releases have always been proved to be very informative in terms of contents.  I think you nailed it correctly by hilighting the hints that we're being given by Dr. Madzarevic  and Dr. Mandel.  These statements are not put lightly.  The wording is well balanced. Anyways, we have 5 major benefits that are impossible

[fredgoodwinson]

Doubtless mutual self-satisfaction all round in respect of the News Releases however infrequent these have become. In contrast the Newsletters (which were pretty much all we got given for so long) could be vague and ambiguous to the point of futility.   Largely cut and paste from the one before on Rutherrin. Now understand that NSCLC will be the sole Clinical Trial indication for starters

[FGPstock]

Rather than specualte,  which is all everyone does on this board. if they really want to World to get xcited about TLT. After they mentioned the tertaaty endpoints and unmet neds they could have just said. "Due to the succes of the Phase II trial, ability to meet all 3 endpoints and the unmet need to a safe and effective bladder cander treatment, TLT has requested BTD from the FDA. This

[fredgoodwinson]

The highest regard for our Scientists and fully understand it to be critical that the exact wording of Trial announcements is precise but yes FGP you are correct. Recent releases have represented a significant improvement on anything we`ve been told for a while  (guessing that this is down to Vera) but there is an important area in which they still look to be falling short. This is - as you

[ScienceFirst]

I don't think that we should be worried about the info. not yet disclosed by TLT management.  They know what they have, the know where they're heading, they know what they have to do to get there. It's highly confidential.  And given that TLT is quite vulnerable in terms of capital, given the OSC thing of Feb. 2018, better keep things low profile until the perfect moment, so

[fredgoodwinson]

Held biotechs for 40 years` now and they`re not for the impatient or risk-averse.    During the 8 year currency of my holding the stock has become a progressively less risky proposition to the point of being now almost entirely de-risked but not all of us are here for the same reason. Some would like to be informed (without any superfluous disclosure of commercial confidentialities

[Rumpl3StiltSkin]

Fred, I can only hope they are holding those juicy PRs for after BTD approval, for Max impact...

[ScienceFirst]

  Yep!  That would be wise.  And that's fair to assume that this is what they're gonna do.   For example, better to wait for the proper time (e.g. Breakthrough designation) to give more details about Rutherrin than too early as a Breakthrough designation would give us huge visibility. You have to be strategic sometimes. _________________  

[enriquesuave]

Anyone know when Q4 end of year 2021 financials come out? If I remember usually end of April and Q1 is end of May.  I believe they told someone who called last November that they would release Quarterly at same time as financials. Next few weeks/months will hopefully have some nice developments and may we see BTD and our SP hit its $1.20 SP target.  

[Yajne]

Reporting deadline is May 2 this year for venture Co's with Dec31 YE. Normally April 30, but since it falls on weekend, the date is May2

[Rumpl3StiltSkin]

I mean imagine what share price would do? I don't think the data was quite there to mention BTD in this last PR, which many here were calling for...   Anyway, once BTD is applied for/approved. Then TLT announces a NSCLC Phase 1 with x-ray activation as it's Dosimetry. Or a partnership with Health Canada for a Covid Vaxx. And, an update of this NMIBC trial with good/better/great

[ScienceFirst]

That's pretty much my reading too. One thing's for sure is that TLT management seem to be in the know that non-dilutive money is coming up soon (jv upfront payment, COVID-19 gov. grants, higher valuation following a Breakthrough designation, money from warrants, etc ...) as Roger wouldn't have added shares last week if a pp was coming. _________________ Rumpl3StiltSkin 

[fredgoodwinson]

Amen Rumpl - there are often good reasons for non-immediate disclosure and total kudos to the Team at our little Company who have withstood a lot - including character assassination - over the years but strongly believe that we might be a long way further down the road if others who matter had been made more aware of what TLT have long before now. Could the market have been kept up to speed