In the MD&A(30-May,2024) you can read it on
https://ceo.ca/tlt(you have to log in first to read it..top right corner).
There is a very interesting quote on page 5(under BTD update).
TLT said'' To this list,the FDA has added: Post Study 11 Monitoring of Response, and
Central Pathology Laboratory Review. What is a Central Pathology Review?
'' Central Pathology Review(CPR), initially designed as a mesure of quality assurance, is incresingly being recongnized as a rapid approach to achieve more uniform diagnostic criteria, especially for
rare and difficult-to-diagnose patients''. Centra Pathology Review apply to all data including the BTD data.
Question? What is a
rare and difficult-to-diagnose patients? If you look at the last Corporate Presentation (03-19-2024), page 14.
-TLT said '' Ruvidar treated patients that have failed therapy with BCG,Systemic PD-L1 immunotherapies and chemotherapies, intravesical oncolitic viruse and intravesical chemotherapies( gemcetabine with or without docetaxel).
-Age of patients
71-80= 54%
81-90 =10%
Total 64% of patients are over 71 years.
-Previous BCG treatments.
13-19 = 19%
over 19 treatments = 21%( that is what you call heavily pretreated patients).
Total of 40% of patients have received over 13 BCG treatments.
All the above indicate that a big part of the patients treated by TLT-Ruvidar are older patients that have a very long and complex medical history, with this type of patients it is more difficult to diagnose precisely why after being CR the cancer has returned?
-Was it because the patient was untreatable in the first place?
-Was it because the patient had a low immune system?
-Was it the treatment itself?
-ETC...
The FDA need more detailed and accurate data from the Central Pathology Review Laboratory to answer as many interogations as possible before giving BTD approval(theFDA has never before approved such an innovative PDT treatment=more questions).
No other BCG resistant treatment treat the same old and heavily preatreated patients as TLT-Ruvidar.
-Valrubicin=no
-Keytruda=no
-Adstiladrin=no
-CGO Oncology(CG0070)=no
-Anktiva(N803+BCG)=no
-And unlike all the above treatments TLT-Ruvidar has no restrictions.
You have to give credit to TLT for treating old and difficult to treat patients that nobody else is treating
(I have always wondered if the FDA take this fact into account before rendering a decision for BTD approval). In short ...
For now the uniqueness of TLT-Ruvidar is slowing down the BTD process, but on the long run the uniqueness of TLT-Ruvidar will make this treatment superior to anything out there.
The fact that TLT has commenced receiving the data that the FDA is asking for is a good sign, up until now the data received seem to be positive, the remaining data could possibly not be very far behind.
Note 1) The PP...Roger Dumoulin has always find ways to finance TLT, and that will continue.
Note 2) The SP...Only a very little numbers of shares are traded each days(with a few Cross Trading) and some days with 0 shares traded.
What does that tell you?
1) Nobody is pannic selling.
2) 99.9?????% of the shares are still in the hands of strong believers.
Always remember, as we speak TLT has a big foot inside the FDA, and the FDA is working
with TLT to achieve BTD approval.
Until all the data have been received, we will have to endure the low SP.