RE:RE:RE:Pioneering is never easy...Eoganacht, excellent summary.
In your post about Adstiladrin 23.5%CR.
Is it ok to say that because Adstiladrin can't treat immunodeficient patients, it does become difficult to compare Adstiladrin CR% with Ruvidar CR%, Ruvidar being safe for immunodeficient patients.
What I am trying to say is, if Ruvidar was treating the same type of patients with the same restrictions as Adstiladrin, Ruvidar CR% would be higher.
Because it is much more difficult to treat a patient who is immunodeficient than treating a patient who has a good and active immune system that help in fighting the cancer(like Adstiladrin patients).
Eoganacht wrote: Merck's Keytruda, as an NMIBC treatment, has already been far outdone by the FDA approved Adstiladrin, both in terms of efficacy and safety. This is what Dr. Peter Black (principle investigator of Theralase's phase 2 trial in BC) said about using Keytruda.for BCG-unresponsive NMIBC.
"...Considering the toxicity, death rate, and risk of progression to muscle-invasive bladder cancer, it is challenging to justify the use of immune checkpoint inhibitors in BCG-unresponsive non-muscle invasive bladder cancer. They should be considered a last resort when no other options are available, or if the patient cannot undergo cystectomy...." Theralase is outdoing both Adstiladtrin and Keytruda.
Comparative CR rates at 12 months:
Keytruda - 18.8 % Adstiladrin - 23.5 % Ruvidar - 27.9 % -
Theralase's
Oct. 15 2024 Corporate Presentation devotes 2 pages to showing how Ruvidar PDT stacks up against the competition - both the 4 FDA approved treatments and 3 treatments still in trial. See pages 21 and 22
https://theralase.com/wp-content/uploads/2024/10/Theralase-Corporate-Presentation-10-15-2024-2.pdf When complete 36 month data is available I believe Theralase will have demonstrated a higher durable response rate than any and all competition, approved or unapproved. When combined with better safety and with only one or two treatments required, I think urologist-friendly Ruvidar PDT is headed to becoming the new standard of care for BCG-unresponsive NMIBC.
Maxcitrac wrote: OCT 7,2024 Theralase update.
Theralase wrote:
Theralase is actively seeking partnering/licensing opportunities. Wildbird wrote:
TLT-Ruvidar with 43.6%CR is 130% more potent than Keytruda at 450 days(MERCK must freak out seeing those numbers). Keytruda is the best treatment that MERCK has for BCG resistant patients.
What are the chances, that Dr.Lbiati(TLT director) has already contacted MERCK, to let them know that Theralase is
actively looking to sign a deal with a big pharma like MERCK.
I am 100% sure she already did.
The deal will naturally be conditional to the FDA granting BTD approval.
Its coming, it is just a question of giving the FDA and Theralase, time to check all the boxes.
wildbird1 wrote: The real problem right now, is not the FDA or TLT management, the real problem is the innovative aspect of this new treatment.
The FDA has never before been asked to grant BTD to such an innovative PDT treatment.
You have to remember that when granting early BTD approval, the FDA has to be very carefull not to make any mistakes that could endanger future patients safety.
As we speak the FDA has no preceding references to judge this new PDT treatment, the only option that the FDA has to evaluate this new treatment is to analyse as much data as possible.
That is why TLT has to provide the FDA with the full set of data that the FDA requested in the first place in 2023, + the FDA request for post study11 monitoring of response.
On a more positive note...
In the last update 27 Nov 2024...
TLT said'' TLT has received the majority of the clinical data from the CSSs, with a high percentage of patients showing a duration of their CR beyond 450 days''.
The above indicate that TLT could be very close to having all the data the FDA is asking for, and the post study11 data are looking pretty good.
More positive notes...
- 43.6% of patients that responded to the treatment are still CR at 450 days.
-Keytruda...18.9% of patients that responded to the treatment are still CR at 450 days.
TLT-Ruvidar with 43.6%CR is 130% more potent than Keytruda at 450 days(Merck must freak out seeing those numbers).
-Adstiladrin...23.5% of patients that responded to the treatment are still CR at 450 days,
TLT-Ruvidar with 43.6%CR is 85% more potent than Adstiladrin at 450 days.
1) I love repeating, that Keytruda and Adstiladrin with much lower CR% data + side effects+ many restrictions, did receive the FDA BTD approval.
2) The above impressive CR% will also be used by Dr.Lbiati to negotiate some Big Pharma deals(maybe Merck).
The big SP drop...
The big SP drop was done with a very low number of shares traded, +99.6% of TLT shares didn't change hands and are still in the hands of strong believers.
Note: This SP drop is a texbook exemple on how to bring down the SP minus 30% with less than one half of 1% of the total shares out count traded in one day.
Right now TLT- Ruvidar BTD approval is being slow down by the innovativeness of this new PDT treatment, and by the FDA wanting as much data as possible to properly evaluate this new PDT treatment.
But once approved, the innovative aspect of this new PDT treatment will be a very big plus, that will push TLT to stardom.
Until then we will have to endure a low SP. At least we get to enjoy the very funny and weird bashing of this stock by Michael.B.DumDum and his minion subordinates.
Note: Nice entry point for new investors.
I still love my TLT shares.