2 solid endpoints...While we wait, here are some interesting facts for the newcomers to this board.
PressRelease Oct 16,2023...
Dr.Mandel TLT chief scientific officer...Said " These patients have failed the standard of care, such as BCG therapy and a
large majority have failed treatment with various modern
immunotherapy drugs.
Immunotherapy drugs.
The best Immunotherapy drug already approved by the FDA is Keytruda(19%CR).
https://keytruda.com/side-effects/ In this link...Keytruda has 3 pages of side effects, serious side effects include death.
In short, Keytruda was approved by the FDA because of a lack of better treatments.
Gene-therapy.
Dr.Mandel doesn't mention Gene-Therapy(Adstiladrin).
Because of it's very big immunodeficient restrictions, Adstiladrin is not worth mentioning.
Suffice to say that if TLT-Ruvidar was treating only the same patients as Adstiladrin, TLT-Ruvidar CR% would go through the roof.
Breakthrough Therapy.
https://fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy In this link...First paragraph...
The FDA said " Breakthrough Therapy designation is a process designed to expeditate the development and review of drug that are intended to treat a serious condition(BCG-Resistant) and preliminary clinical evidence(20-25 patients) indicates that the drug demonstrate
substantial improvement over available therapy on clinically significant endpoints(s)". TLT-Ruvidar has a 34%CR(optimized).
As we speak the best FDA approved treatment for BCG-Resistant patients is Keytruda(19%CR).
TLT-Ruvidar is 80% more potent than Keytruda.
I guess we could easily say that with "80% more potent than Keytruda" TLT-Ruvidar does qualify with regard to
subtential improvement over available therapy. Although for the FDA TLT-Ruvidar 34%CR being "80% more potent than Keytruda" is a very solid endpoint, there is another endpoint that is crutial for the FDA, and it is safety. Safety is the tertiary objective. TLT-Ruvidar is 100% safe. 100% safe is a huge
improvement over available therapy(Keytruda). 1) These two solid endpoints improvements over available therapy are the main reason that the FDA has no choice and will give TLT-Ruvidar BTD&AA.
2) These two solid endpoints will be very usefull in Dr.Lbiati discussions with big pharma.
3) These two solid endpoints will increase the $value of a Big Pharma deal.
If you are a newcomer on this board and you understand the above, you are at the right place at the right time.