Theralase Technologies Inc. V.TLT

N-803 had been granted Breakthrough designation. We will too

[ScienceFirst]

Look no more.

If ImmunityBio's combo (N-803 + BCG) has been granted Breakthrough designation for the same indication as ours (BCG-unresponsive), then there's no reason for TLT not to be granted similar Breakthrough designation by the FDA.

The FDA granted Fast Track Designation to the pivotal trial based on Phase I data.

In December 2019, the FDA granted ImmunityBio Breakthrough Therapy Designation based on interim Phase 2 data indicating the primary endpoint of the trial was already met.

[ScienceFirst]

It's impossible that TLT not be granted Breakthrough designation when you read carefully the news release of ImmunityBio's of Dec. 2019, as we clearly see the goal of the FDA: Dec. 4, 2019: ImmunityBio Granted FDA Breakthrough Therapy Designation for N-803 IL-15 Superagonist in Non-Muscle Invasive Bladder Cancer Results of Phase 1 and 2 studies in BCG Unresponsive Non-Muscle Invasive

[FGPstock]

nothing is guaranteed w tlt, except for high saleries, stock options and cash bonuses...

[ScienceFirst]

FGPStock ... You sound so much like our libertarian armchair quarterback Bungee ... ;-) I wonder how entrepreneurs that became multi-millionaires and multi-billionaires ended up there.  You should do us a demonstration.  Or show us the incentives and salaries of other biotechs management.  Just for fun. You think TLT management would be overpaid if we go commercial after 15y

[FGPstock]

People should be paid on performance, the stock it at 28c, I am pretty sure your revenue prediction of jan 2023 isn't going to happen. you like to being politics into every discussion when you disagree w someone. You seem like a perfect policticain tho, when something doesn't work, just try to change the sunject or post 101 examples of other companies being bought out. If we all lose our

[ScienceFirst]

FGPStock ... I just go head-to-head with you because you lack judgment and lack respect for those that try something good that could positively benefit many.   You also post on things you're not even to keep yourself up to date (*1). And again, show us how TLT's management is way more overpaid versus other biotechs versus where we could land.  Just for fun.   You over

[Infinity]

Hey Science first,  I will agree, you have some good points.  However, you are beginning to sound more and more like Roger's Pit Bull.   

[socksnblonds642]

I just don't understand what Fuhgupkuh stock (pronunciation?) is on about and why such effort to complain. I could be mispronouncing his name, sorry Fuhgupkuh if I am.  Very grumpy. Needs a warm bowl of soup. Some excellent reads on here otherwise...

[ScienceFirst]

Coming from the guy: - that first swamped this board on April 5 with 40 consecutive posts in 1 day vomiting on TLT management  - that has not even taken a look at the corporate presentation yet - that had no clue on what it could be associated with - that cannot make a distinction between what's under the control of TLT and what's not - that is confusing things because he's

[Infinity]

Hey Science first,  What is your point, apart from verbal onslaught on every one.  You migh as well advertise yourself as a Pumper..

[ScienceFirst]

Infinity ... Only with FGPStock. ... ;-)

[Infinity]

Yes, we need more rational posts on this board.

[FGPstock]

I am the rational one that likes to deal w facts and truth. Bencro likes to change his tune based on the day. One day BTD granted Nov-Dec, then next "applied" for in Nov-Dec, using the same document as his reference. In the past ppl said bencro and roger were one in the same. I didn't think it was true for a while, but they both like to troll stockhouse, have the same ego and have

[ScienceFirst]

Oups!  Our dinosaur-in-chief FGPStock is telling us that between May and October 2022, nothing had evolved!  That he was able to foresee results! lolll   On the other hand, he was posting garbage whining based on outdated information because he wasn't up to date! Then he blames others. lolll https://stockhouse.com/companies/bullboard?symbol=v.tlt&postid=35093119

[BlueFranky]

Sciencefirst - thanks for keeping it real while we await the results Appreciate your efforts as always

[wildbird1]

ScienceFirst great catch...(the best catch I have seen lately). If we sum-up, for the FDA, the new goal for NMIBC patients(like TLT patients) would be Avoiding Cystectomy(removal of the bladder). The above is one more proof as to why TLT has always included a TR%(CR+PR) line in their NewsRelease data. PR Patients. Partial response patients are patients that still have their cancer, but the tumor

[Oilminerdeluxe]

Forgive me if this question is stupid, but is there a risk the FDA instead says: "Ok, this looks promising, but we want 20-25 optmized patients befor we make a decision." ? I have to ask. 

[Yoly900]

This post has been removed in accordance with Community Policy

[Yoly900]

Now that's a great CATCHHHHH

[StevenBirch]

My understanding is it's 20-25 patients so maybe there is an allowance for less if the results are superior. To make an exaggeration, let's say they were 100% CR, 23 out of 23, and waiting on 2 to get to 25 total. Why make them wait another couple of months possibly? At least as far as applying for BTD anyway and hopefully we would get that info. Isn't that where the 'frequent

[Yoly900]

ROGER WHITE GIVE ME CHRISSY ! I'm cuminnnn for ya chrissy Putin COMEIN for yu roger Arkady mandeluschi 2.00 doctor shoemskerrree

[Oilminerdeluxe]

Thanks Steven. Maybe a little Fomo this week can brighten the mood.

[StevenBirch]

That's the plan Oil.