Theralase Technologies Inc. V.TLT

Accelerated Approval - what are the chances?

[Eoganacht]

8 out of 29 patients (28%) have hit at least 450 days completely cancer free. 

 

Remove the 12 undertreated from the calculation to see just the optimized resu ( these 12 are mostly little different from the first 3 half-dose patients from the phase 1b ) and you have these optimized results at 450 days:

8 out of 17 ( 47% ) patients cancer free (including 3 full dose phase 1 patients) and
6 out of 14 ( 43% ) patients cancer free (including only phase 2 patients)

 

Surely those numbers, along with the extremely high safety, should be enough for AA.

 

I'm sure the 6 phase 2 patients who no longer have bladder cancer think so.

[N0taP00p]

Certainly makes me want to buy more. :)

[stocksnbonds458]

Well Eoganacht, apparently Immogene received Accelerated Approval with a 5% CR so hopefully we will be a sure thing.

[Kingpin68]

SF, Thanks for putting up those stats removing the under treated. Very, very encouraging.

[Kingpin68]

Sorry, that was Eog's post  And, how do we not get BTD and AA basd on those numbers. I keep buying when I can.

[enriquesuave]

Those are CR patients, plus we have PR patients some of which may end up CR if proven to have UTUC 

[riverrrow]

Wow!!!   Terrific cancer treatment numbers. This is the first time I've seen the numbers laid out like this from the recent clinical trial results.  Thanks for posting.  GLTA.

[Oilminerdeluxe]

Those are the numbers I have waited to see. Thank you very, very much. Hope the FDA likes them too.

[Infinity]

TSX.V had less than 42000 sold today.  Positive indication.  Nobody is willing to sell at these low prices.  All Long holders are aware that we have a winner in our hands.  Great study results.  I am sure, FDA is aware of initial 12 under treated patients who are still in the study knowing that this is the best treatment to avoid the worst case scenario of Cystectomy. 

[ScienceFirst]

Eoganacht... Excellent post.  Thanks for sharing. This is what I would have expected from an analyst like Ubbin covering TLT.   You deciphered our data in order to make a comparison between 2 subset groups (undertreated group versus optimized group).   This then allows us to compare the best subset group DR % against other Accelerated Approval winners like KEYTRUDA in our own

[BlueFranky]

Eoganacht... Thank you so much for arguably, the best post I've seen this year.. I do believe this needs to be sitting in front of the center on every screen Awesome!   

[BlueFranky]

...like I said, front and center! Thanks again Eoganacht.. for your post below, of this day: Accelerated Approval - what are the chances? 8 out of 29 patients (28%) have hit at least 450 days completely cancer free.    Remove the 12 undertreated from the calculation to see just the optimized resu ( these 12 are mostly little different from the first 3 half

[CancerSlayer]

  Thanks Eoganacht....Uddin certainly needs to do more homework next time ; ).   I stopped considering those undertreated in my "personal" calculations/investment decisions the day I heard they were undertreated (7/30/2020).  And looking forward to the day we can finally nix "optimized" from "optimized patients".   Though the terminology was

[Yoly900]

WE WILL FAIL AND BE DELAYED TIL 4th quarter 2023 than 0.002. First we will hit 0.37 selloff back to 0.17 and than bull delays will be in affect Oct warrants will be extended agsin roger and company will rebuy and stock options WE WILL VOTE YES TO STOCK OPTIONS THATS BULL ALSO. One big VICIOUS CYCLE OH COVID VACCINE 2024 gotta love whst about all work 2 years time guess what nothing was done

[ScienceFirst]

What's even more in our favor is that the FDA doesn't only consider CRs but TRs (CR + PR).  So our TR for the optimized group is already above 50%. Considering what's at stake, bladder removal, anything that can delay its removal or that can preseve it, should be welcomed and offered as a new alternative to patients.  That's the spirit of the AA program. _______________

[ScienceFirst]

Below, so many similarities with the type of our NMIBC study.  And we have much higher CRs.  And much higher DRs. Already being superior to KEYTRUDA, FGPFUD should have had the critical regard to question why analyst Uddin didn't come up with any minimum exhaustive research comparing our CR % with recent CR % of recently AA winners, considering how AA can be a game changer for a

[ScienceFirst]

Below is another recent Accelerated Approval example showing only a 3% CR that you would have expected analyst Uddin to put into perspectives and annexed to its report analysis so his Clients could be in a better position to assess the magnitude of our CR %.  FGPFUD should have had this basic critical stance toward the report of analyst Uddin.  But he cannot as he doesn't do

[ScienceFirst]

That's exactly how our Ph. 2 trial is designed.   10. Accelerated Approval (Subpart H and Subpart E) Considerations ... In BCG-unresponsive NMIBC, a single-arm clinical trial with complete response rate and duration of response as the primary endpoint can provide primary evidence of effectiveness to support a marketing application Source:  The new 2018

[ScienceFirst]

Our chances are high, as we fit the definition of the FDA.  Definition that TLT has specifically added to its web site. Taken at the bottom of this TLT webpage:     FDA guidelines (February 2018) for BCG-Unresponsive Non Muscle Invasive Bladder Cancer states that: “In BCG-Unresponsive NMIBC, a single-arm clinical trial with Complete Response ("

[Infinity]

Thanks Eog,  You have hit the nail on the head so to speak.   I believe you have done your research better than many others on this board.  Thank you for your time and sharing your thoughts.  May I ask you to publish the results for the first 12 under treated patients.  I understand that many are still in the clinical program and continuing to place their trust with

[Yoly900]

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[Yoly900]

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[Yoly900]

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