wildbird1 wrote: Food for thought (Part 1)...
ImmunityBio-Anktiva(N803+BCG) and Adstiladrin are the two best and only treatments for BCG resistant patients that did receive the FDA-BTD approval.
ImmunityBio-Anktiva...Has a relatively good CR%(but lower than TLT-Ruvidar), but there is a big catch with ImmunityBio-Anktiva.
In this link...
ImmunityBio Announces FDA Approval of ANKTIVA®, First-in-Class IL-15 Receptor Agonist for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer - ImmunityBio Check, point no-4 (under the date...).
It said '' Anktiva in combination with BCG is approved for
maintenance therapy for up to 37 months''. What is a maintenance therapy?
In this link...
Definition of maintenance therapy - NCI Dictionary of Cancer Terms - NCI It said'' Treatment that is given to help keep cancer from coming back after it has disappeared...and
it may be given for a long time'' -Right away you can see that ImmunityBio-Anktiva is not in the same class as TLT-Ruvidar a one and done treatment that can cure the cancer.
The interesting part is, that the FDA gave Anktiva BTD approval for a
maintenance therapy that can last 37 months, and doesn't even cure the cancer.
Adstiladrin...
In this link...
Adstiladrin Interactions Checker - Drugs.com It said '' There is 288 drugs know to have a major interactions with Adstiladrin''.
In this link...
Adstiladrin: Package Insert - Drugs.com Under 5.2 Risk of....
It said '' Individuals who are immunosuppressed or immune-deficient, should not come into contact with Adstiladrin''.
In spite of the above, the FDA gave Adstiladrion the FDA-BTD approval.
Note: TLT-Ruvidar doesn't interact with any drugs, and being 100% safe, it will treat immune-deficient.
Government insurance programs.
In this link...
ImmunityBio’s ANKTIVA® Now Covered By More Than a Dozen Insurance Plans Representing Over 100 Million Lives Within Months of FDA Approval - ImmunityBio It said '' ImmunityBio,Inc.Today announced significant progress in market access, making Anktiva widely available to patients through both commercial and government insurance programs.
Question.
Why would a government insurance program, pay for a 37 months long maintenance therapy that doesn't even cure the cancer?
Answer..
Because they have no better options. All the FDA approved treatments for BCG-resistant patients are either continuous treatments(
Anktiva, CG007,Keytruda) or have severe restrictions and a very low long-term CR%(
Adstiladrin, Valrubicin).
What make all the above interesting is ...
Until somebody comes up with a better treatment for BCG-Resistant patients, when the FDA will approve TLT-Ruvidar(and they will, it is coming), TLT-Ruvidar will be the only '' one and done treatment'', 100% safe, with the highest long-term CR% in the business, that will be available for commercial and government insurance programs. Difficult to place a $value on the above.
More food for thought(part 2).
In this link...
pipeline - ImmunityBio It said'' Anktiva+BCG for BCG unresponsive is ImmunityBio
only FDA approved treatment. In May 2024, after the FDA approval of Anktiva+BCG
maintenance therapy, ImmunityBio SP did climb to US$9.00(Nasdaq), today US$4.00.
ImmunityBio has 700 million shares out, for a 37 months long maintenance therapy that doesn't even cure the cancer.
-TLT has 235 million shares out(335 million after the PP), and a treatment that can cure the cancer, is 100% safe, and has the best CR% in the business for BCG-Resistant patients(including Anktiva and Adstiladrin). The SP...As is usual the low SP and the puny little numbers of shares traded each day doesn't mean squat to me.
The PP.. When needed, R.Dumoulin always find ways to finance TLT, and that will continue. Competitors...
Anktiva being a maintenance therapy, the only real competitor to TLT-Ruvidar is Adstiladrin, and Adstiladrin has severes restrictions, and a very low long-term CR%.
To wrap up...
The FDA, the patients, and the big insurance programs, they all badly need TLT-Ruvidar.
'' Fortune sides with him who dares''(virgil).