Theralase Technologies Inc. V.TLT.W

2 weeks: It’s all it took for Merck to get AA

[ScienceFirst]

2 weeks!

It's all it took for the FDA to grant Accelerated Approval to Merck in 2020 for the same condition as ours.

That would explain our "Commercial revenues (projected)" milestone so close to the p#25 450-days. 

Having superior data than Keytruda, it's legitimate to think that we could see similar response from the FDA.

First time I see this.  For BCG-Unresponsive, Merck obtained the Accelerated Approval.
In 0.5 month!

BLA 125514 Supplement 79 4
KEYTRUDA
PEMBROLIZUMAB
MERCK SHARP & DOHME

4/14/2020
4/28/2020

0.5

PROVIDES FOR AN ALTERNATE DOSE/SCHEDULE OF 400MG EVERY 6 WEEKS FOR ADULT PATIENTS WITH BCG-UNRESPONSIVE, HIGH RISK, NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC) WITH CARCINOMA IN-SITU (CIS) WITH OR WITHOUT PAPILLARY TUMORS WHO ARE INELIGIBLE FOR OR HAVE ELECTED NOT TO UNDERGO CYSTECTOMY

[Tapps21]

And how long did it take to approve Oxy? A community destroying embarrassment.  That's what I was trying to get at in my previous post. With all the recent positive literature about our miracle in the making, all the hoops being jumped through, we should be a sure shot as TLT has saved many bladders already. 

[CancerSlayer]

  Nice find SF....Considering we are not a systemic drug (fewer reported side effects & less risk for serious adverse events), we are only a 2 dose treatment (vs 30+ doses for a full course of Keytruda; bladder instillation time of ~2 hrs vs IV infusion time of 15+ hrs), our current 12 month CR rate is trending significantly higher (28% vs 19%), & the total cost of our two-dose

[thadeush]

While I totally agree, the jaded side of me has never seen big Pharma see lower cost as a good thing. They do love their profits. 

[ScienceFirst]

Thadeush ... Then why are you invested in TLT, knowing they only have a 2 doses treatment??? So you're saying that laparoscopy surgeries would then have never became mainstream.  Same for Lasik?  And what about arthoscopy surgeries, etc ... It is always academic institutions like PMCC (UHN), McGill Health Center (McGill Univ.), private clinics, etc ... that lead the way with

[Rumpl3StiltSkin]

I think ultimately the market will get this one right. Remember, there are many pharmas and biotechs who will want something like this, just to compete...  So 20k per treatment seems steep, yet it is only 2-3 treatments. Still, lots of room for profits $$$ as the acquiring pharma will produce very large batches. Shelf life and storate space shouldnt be a concern either, not for a pharma. That

[skys1]

Rumpl3, You consider $20K for 2 treatments or $40K total "steep"? Compare it to the current Standard of Care. $15K each every 3 weeks, ad infinitum!! Total who knows, but well into the 6 figures!

[ScienceFirst]

TLT once mentioned 100K$US, just a bit below Keytruda cost.  Enough profitability, while being just below KEYTRUDA cost, but with less treatments and higher efficacy.

[Eoganacht]

Yes, the current corporate presentation uses this number as an average ($USD 50,000 to $USD 150,000) to estimate an NMIBC market opportunity of $USD 5 Billion annually. See page 7. https://theralase.com/wp-content/uploads/2022/07/Presentation-2022.pdf

[99942Apophis]

Thanks Eoganacht interesting is that figure represents the Canadian and US markets while clinical trials are being done in each country, Europe was originally going to be included was dropped because of a higher cost. Worldwide NMIBC cases comes in at an estimated 573,000 which would put the North American percentage at 17% of new world cases. I don't know how long it takes ( months or years )

[Rumpl3StiltSkin]

It seems steep to a layperson, sucn as me... Yet I was just throwing that figure out there. I have no idea at what price the markets will eventually settle. You are correct about 1433 being relatively VERY cheap compared to SoC today. Once all costs are added up. even at a much higher price per treatment than $20K

[FGPstock]

I think all of us including myself were confused with Research Capital. AKA Mackie, Theralase's main go to for financing and analyst coverage dropped its target from $1.20 to .80 and pushed out revenues to 2026. Most of us are looking for a $10-100 target. If TLT was able to get AA it would allow them to generate some revenues. Why the anaylst pushed them back to 2026 seemed odd, then I looked

[Eoganacht]

You're making a mountain out of a molehill. There is no significant difference between the August 2022 and November 2022 news releases. Go back to earlier news releases to the sections on BTD. The June 2021 news release mentions accelerated approval: "As a Fast Track designee, Theralase® has access to early and frequent communications with the FDA to discuss Theralase®’s

[FGPstock]

Eog, I hope you are right, but why would their analyst, who most likely knows more than anyone on this board push revenues out to 2026 and reduce the price target right after the PP? When is the last time you have seen TLT talk about revenue in 2023. Why would Uddin say he felt TLD was a better option then Keytruda, then lower his price target and push out the launch to 2026? Don't you think

[ScienceFirst]

FGPStock ... Why are you so heavily invested in TLT (as per your own saying) when you always raise issues with this stock? lolll

[FGPstock]

Didn't say I was selling. Just trying to figure out why the person who knows more than all of us just pushed backed the revenue target 2 years I don't need to be a pumper like you to invest in a stock. I look try to look at things objectively. You should give it a try. He also expects 2022 ($907,000) and 2023 ($998,000) to come in below the $1 million mark in terms of revenue, but he

[ScienceFirst]

FGPStock ... Bungee too thought some were pumping.  After 2y documenting things with sources just for him, the libertarian clown thought Keytruda was a threat to TLT in terms of efficacy, number of doses, QOL, etc ...!  His sudden "Hurry up TLT" made history!  Loll - Tell us where we don't fit the AA program and why?   - List us what boxes we check in the spirit

[FGPstock]

Ben, you are a pumper as none of your posts are objective. You also have pretty thin skin as it seems you still think daily about someone who posted on this board years ago. Everything I mentioned are very clear statements made by the company and its only analyst. Usually, people change their position regarding revenues being pushed back 2 years based on something. If Uddin thought AA and revenues

[Lesalpes29]

FGP see pumpers everywhere! Take a break man, you are trying hard to find something negative in a story that you own. Maybe you have to sell if you have shares of course! And you pop up when the stock is green. Bizarre no!

[ScienceFirst]

FGPStock ... I remember when you first posted here, your timing had been poor.  Just like Bungee.   You posted 40+ consecutive garbage posts on TLT management.  It happened that you lacked ooor judgment as TLT brought this treatment to the doors of BDT and AA.  All this at lower cost than any other biotechs.  Prove me wrong with numbers, as you deflecting from your

[ScienceFirst]

FGPStock ... Tell us, - did analyst Uddin had access to TLT management? - did he had access to the content of discussions between TLT and the FDA? - why, or under which reason or under what basis, TLT management would have advanced by 30 months this "Commercial revenues (projected)" milestone?  Try to respond to this one please. - did analyst Uddin mentioned that Roche and

[FGPstock]

Ben, I don't have the time, energy or interest to answer all of your questions. Even if I did, you would put a spin on the answers no matter how right i was, but i will answer this one: why, or under which reason or under what basis, TLT management would have advanced by 30 months this "Commercial revenues (projected)" milestone?  Try to respond to this one please. My response

[ScienceFirst]

FGPStock ... Don't deflect in that one too _____________ FGPStock ... Tell us, - did analyst Uddin mentioned that Roche and Merck obtained AA in the bladder indication and why TLT wouldn't qualify for? - did he had access to the content of discussions between TLT and the FDA?  

[ScienceFirst]

FGPStock ... Are you telling us that analysts have a 100% batting average? How can this gimmick be possible? As expected, Research Capital is quietly selling into the rally. I suspect they are still dumping those $1.05 PP shares they underwrote a few months ago. Looks like a quote from your previous SH avatar ... The one before you created this one on April 4 ... ;-)  

[Infinity]

Management report of 29th November, does not seem to indicate any extension to the commercial revenue projections that they made earlier.  I stil expect their previous projection date of 1st quarter of 2023 to be the estimate for commercial revenue.   The report of 29th Nov, has more clarity, meaning that they have provided actual Number of patientsand the results at different dates

[Oilminerdeluxe]

Everything always takes longer than one thinks. But at least it feels like TLT is closer than ever to get a rerating. Those BTD and AA would be nice to have as fast as possible to aid in that quest. Hope they have compiled it on time and FDA works without too many time consuming hiccups. A fresh juicy update would be nice to digest.

[Eoganacht]

Hi FGPstock - I think you've got things mixed up a bit. There can't be any launch of TLD-1433 sales in 2024 without accelerated approval. Assuming we treat all 100-120 patients by the end of 2023 we will have to wait another 450 days before applying to the FDA and HC for approval which will bring us to 2025. What you quoted below is from an older report by Dr. Uddin. Currently he does not

[FGPstock]

Eog, I hope you are right. The statements are only a few months apart and correspond with TLT taking the stateme nt out of their financials. Below is a statement from your friend Ben sayin revenue in jan 2023. Who do you trust, someone like ben who changes his opinion daily, or someone who has more access to tlt management than any of us... ScienceFirst (7869) User Actions  

[ScienceFirst]

FGPStock ... yYou posted that abakyst Uddin had access to TLT management.  Do you have any proof of that?

[ScienceFirst]

FGPStock ... You posted that analyst Uddin had access to TLT management.  Do you have any proof of that?

[FGPstock]

First, it is typical for analysts to talk to the companies they cover. How can you even question that. Second, Research Capital/Mackie has been involved in almost every capital raise TLT has done in the past 5+ years. Are you suggesting that Research Capital and TLT management don't talk? Again, you keep deflecting. Why would the companies only analyst push back revevnues 2 years when you say

[Camphikefish]

You gentlemen crack me up. Call me weird but there's a lot of humor watching you two go back and forth. I must say though SF it seems to be a couple of worthy, legitimate and straightforward questions. I always respect your comments like everyone else and your thoughts on the analyst would be helpful to all of us. 

[FGPstock]

thanks cfish, ben and i are actually really good friends. he just drinks a lot :)

[ScienceFirst]

FGPSTOCK... Who do you trust more?  And why? - TLT management that had direct access and frequent meetings with the FDA? or - An analyst that come up with very little arguments.  Or simply silence key pivotal imminent events?   Remember, he's been silent not only on Accelerated Approval but also Breakthrough Therapy designation.  Don't you find it strange

[ScienceFirst]

FGPStock... Don't deflect on this one below _______________   ScienceFirst - (12/7/2022 11:02:29 PM) RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:2 weeks: It’s all it took for Merck to get AA FGPSTOCK... Who do you trust more?  And why? - TLT management that had direct access and frequent meetings with the FDA? or - An analyst that

[Legit62]

He is not an insider and has no access to Theralase management, he would have inside knowledge and its illegal, he is making an educated guess like all of us, bottom line is only 3 people know when we will really achieve the BTD and AA , which of course the FDA controls, i will say from Data improving, we should be pretty close since what we do and how we do it smokes Keytruda. I didnt make that

[Legit62]

He basically knows what we all know, unless they specifically told him we are not getting AA until 2026, which again is inside info and not made public so aint happening

[N0taP00p]

I have been buying in the hopes that they do get BTD and AA but FGPStock's concern is legit and I share it.  Just can't shake the feeling they'll drop another delay and try to explain it away.   Obviously, hoping I'm wrong.  

[99942Apophis]

Am I reading this correctly? There isn't one side to that coin you have flipping in the air,  the other side would be what? That they could be about to get it sooner!  As I weigh data I only see impressive improving numbers I can't say yes or no on what will happen. True you and many have been here much longer than myself and I do admit that I'm probably still green on how

[ScienceFirst]

N0taP00p ... Again, we're all at the mercy of a FDA decision as they're the regulators. TLT management had discussions with the FDA.  So they know more than anybody else, though they're also at the mercy of a FDA decision as the FDA is the regulator. Here, we are now aware of the AA possibility and why.  Everything has been documented so we all know what's at stake and

[Rumpl3StiltSkin]

Anyone notice that notapoop backwards is poop a ton? :-)

[Pandora]

I believe there was a pool being run to see who would be the first one to pick up on that!

[N0taP00p]

You've just hit the jackpot Rumpl and Pandora. Spend it in Vegas. :) I'll be there too hopefully. 

[StevenBirch]

Thanks Eog, analysts price targets mean absolutely nothing. Reminds me of the joke in Goodfellas where a guy goes to the doctor, the doctor gives him 6 months to live and when he says he can't pay the doctor gives him another 6 months to live. In fact I don't ever remember seeing a stock actually hit a projected target, they either get adjusted up or down before the stock gets there, as

[Eoganacht]

I believe in previous corporate presentations Theralase has estimated a cost of 50K to 150K.

[cantlose22]

This post has been removed in accordance with Community Policy

[DeathXray33]

On 2014-09-22 Sigma-Aldrich was acquired...

[ScienceFirst]

This very complete paper of March 2021 clearly shows that the only 2 FDA approved BCG-Unresponsive drugs are not convincing.  This opens up the road for Accelerated Approval, no doubt. Note also that Keytruda has never received EU approval. BCG-unresponsive high-grade non-muscle invasive bladder cancer: what does the practicing urologist need to know? Until the end of 2020, the

[digitalstone]

Thanks SF for sharing all your research ! Much appreciated !